OnabotulinumtoxinA (VA Office of Research and Development)

- Five scientific e-posters highlight investigational neurotoxin trenibotulinumtoxinE (TrenibotE), demonstrating rapid improvement in glabellar lines (as early as 8 hours), robust and consistent efficacy, and a favorable safety profile across global patient populations - Real-world and clinical data reinforce onabotulinumtoxinA (BOTOX® Cosmetic) as a foundation for high patient satisfaction, natural-looking results, and the gateway to multimodal facial aesthetic treatment plans - Portfolio-wide results demonstrate continued investment in innovative, integrated approaches for patients and practitioners NORTH CHICAGO, Ill., March 26, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company, will present 21 scientific e-posters at the Aesthetic & Anti-Aging Medicine World Congress (AMWC) in Monaco on March 26-28, 2026, underscoring the company's industry leadership in advancing patient-centric, evidence-based innovation across the spectrum of aesthetics medicine. The data span clinical, real-world and preclinical research, reflecting a deep commitment to driving exceptional results, safety and satisfaction for practitioners and patients worldwide. "At Allergan Aesthetics, our progress is driven by a dedication to generating high-quality scientific data that informs every advance we bring to aesthetic medicine," said Darin Messina, Ph.D., senior vice president, research & development, Allergan Aesthetics. "The breadth and depth of findings presented at AMWC Monaco demonstrate our commitment to equipping practitioners with meaningful scientific insights and innovative solutions, all aimed at delivering safe, effective and individualized outcomes for patients." Investigational Neurotoxin TrenibotulinumtoxinE Demonstrates Rapid Results as Early as 8 Hours and Short Duration with Consistent Efficacy and Safety Research shows that investigational neurotoxin trenibotulinumtoxinE (TrenibotE) delivers rapid results as early as 8 hours, a short duration of 2-3 weeks, and consistent efficacy with safety observed across diverse patient populations. Key Findings: Rapid and consistent improvement in moderate-to-severe glabellar lines, with results observed as early as 8 hours and comparable efficacy and safety across East Asian and North American/European populations Effective and well-tolerated in both toxin-naïve patients and those previously treated with onabotulinumtoxinA (BOTOX® Cosmetic), supporting use across treatment histories High patient satisfaction with natural-looking results, along with improvements in psychosocial outcomes following treatment Early evidence supports sequential treatment with TrenibotE followed by onabotulinumtoxinA (BOTOX® Cosmetic) as a well-tolerated and effective approach for glabellar lines BOTOX ® Cosmetic: Patient Satisfaction, Natural-Looking Results and Integrated Aesthetic Care Recent studies on onabotulinumtoxinA (BOTOX® Cosmetic) solidify its position as the leading neuromodulator in facial aesthetics globally, delivering high patient satisfaction, natural-looking results and improved psychological well-being. New real-world data show long-term use is frequently followed by adoption of additional aesthetic treatments. Key Findings: High patient satisfaction and natural-looking results for upper facial lines, with improvements in psychological well-being among toxin-naïve patients Long-term use of onabotulinumtoxinA (BOTOX® Cosmetic) may serve as an entry point to broader aesthetic treatment approaches for patients Patient preference research in China identifies key factors influencing treatment decisions for masseter reduction, including procedure standardization, degree of slimming, duration, side effects and cost Real-world evidence suggests patients receiving long-term onabotulinumtoxinA (BOTOX® Cosmetic) treatment often progress to multimodal care, including additional facial aesthetic procedures over time Injectable Hyaluronic Acid Treatments (VYC-12L and VYC-20L): Clinical Evidence Across Neck, Perioral and Skin Quality Indications Data demonstrate that VYC-12L (SKINVIVE by JUVÉDERM®), a hyaluronic acid intradermal microdroplet injection, and VYC-20L (JUVÉDERM® VOLUMA® XC) are effective and well-tolerated across multiple indications, with up to 6 months of sustained improvement in neck lines, perioral lines and skin quality, alongside evidence of stability, biocompatibility and injector usability. Key Findings: VYC-12L reduces neck and perioral lines, with results sustained for up to 6 months and safety observed across study populations VYC-12L improves skin quality, including cheek smoothness, supporting use across facial indications In Chinese adults, VYC-12L demonstrates significant improvement in perioral lines with high responder rates and durability up to 6 months VYC-20L preclinical and usability data support stability, biocompatibility and improved injector experience New elongated plunger cap syringe shows improvements in injector comfort, ease of use and reduced hand fatigue compared to standard designs HA-CaHA Injectables (HArmonyCa) Demonstrate Durable Skin Quality Improvements, Including in Patients Undergoing Medical Weight Loss Clinical studies demonstrate that HA-CaHA injectables are effective and well-tolerated, delivering measurable improvements in skin quality and midface volume with results lasting up to 18 months. Subgroup analyses also suggest potential benefits in patients undergoing medical weight loss, including those treated with GLP-1 therapies. Key Findings: HA-CaHA injectables were shown to improve skin quality, including elasticity, firmness, tightening and cheek smoothness, extending beyond volumization alone Results are durable, with improvements in midface volume and skin quality sustained for up to 18 months Subgroup analyses suggest HA-CaHA may improve midface volume and patient satisfaction in individuals undergoing medical weight loss, with effect observed up to 18 months Body Contouring (CoolSculpting ® ) Demonstrates Continued Clinical Utility, Including in Medical Weight Loss Patients Body contouring aesthetic procedures, such as CoolSculpting®, continue to have clinical utility in the treatment of patients with stubborn fat and may also play a role in those patients undergoing medical weight loss. Key Findings: Highly desired among women, with the abdomen and flanks reported as the most bothersome areas for stubborn fat High patient satisfaction with helping patients achieve fat reduction in areas resistant to diet and exercise Induces beiging and metabolic activation in white adipose tissue, offering molecular evidence for lasting fat reduction efficacy Collectively, these findings highlight the effectiveness and safety of integrated, layered treatment approaches across the Allergan Aesthetics portfolio. Attendees at AMWC can expect comprehensive scientific evidence underscoring Allergan Aesthetics' leadership in neurotoxin and multimodal aesthetic treatment strategies designed to help practitioners meet evolving patient goals. E-Posters are accessible via the AMWC App and in the E-Poster area (Level -2) of the Grimaldi Forum, March 26-28, from 8:30 a.m. – 6:00 p.m. BOTOX® Cosmetic (onabotulinumtoxinA) Important Information Indications BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: - Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity - Moderate to severe lateral canthal lines associated with orbicularis oculi activity - Moderate to severe forehead lines associated with frontalis activity - Moderate to severe platysma bands associated with platysma muscle activity IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING CONTRAINDICATIONS BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. WARNINGS AND PRECAUTIONS Lack of Equivalency Between Botulinum Toxin Products The potency Units of BOTOX ® Cosmetic are specific to the preparation and assay method utilized. BOTOX ® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX ® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method. Spread of Toxin Effect Please refer to Boxed Warning for Distant Spread of Toxin Effect. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur. Serious Adverse Reactions With Unapproved Use Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established. Hypersensitivity Reactions Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined. Cardiovascular System There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease. Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin. Dysphagia and Breathing Difficulties Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning). Preexisting Conditions at the Injection Site Use caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Dry Eye in Patients Treated With BOTOX® Cosmetic There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist. Human Albumin and Transmission of Viral Diseases This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products. ADVERSE REACTIONS The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%). The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%). The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%). The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications. DRUG INTERACTIONS Coadministration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic. USE IN SPECIFIC POPULATIONS There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production. Please see BOTOX® Cosmetic full Prescribing Information , including Boxed Warning and Medication Guide . SKINVIVE by JUVÉDERM ® Injectable Gel Important Information INDICATIONS SKINVIVE by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Not for patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to Gram-positive bacterial proteins or lidocaine in this product. WARNINGS: Do not inject into blood vessels as this may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention should an intravascular injection occur. Treatment at specific sites should be deferred where there is an active inflammatory process or infection. PRECAUTIONS: Only healthcare professionals who have appropriate training, experience, and are knowledgeable of the anatomy at and around the injection site should use this product . As with all transcutaneous procedures, injections carry a risk of infection . The safety for use during pregnancy, breastfeeding, and in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been established . Use with caution in patients on immunosuppressive therapy. Patients taking medications that can prolong bleeding may experience increased bruising or bleeding at treatment sites. Patients may experience late onset AEs with use of injectable gel implants, including SKINVIVE by JUVÉDERM® ADVERSE EVENTS: The most commonly reported injection site responses included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most were mild, lasting 7 days or less. Please see Directions for Use or visit SKINVIVE.com for more information. SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner. The investigational products described above, trenibotulinumtoxinE for the treatment of glabellar lines and SKINVIVE by JUVÉDERM® for the improvement of neck appearance, have not yet been shown to be safe and effective for their intended uses. JUVÉDERM® Collection of Fillers Important Information INDICATIONS JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face, for augmentation of the chin region to improve the chin profile, and for supraperiosteal injection to augment the temple region to improve moderate to severe temple hollowing in adults over the age of 21. JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21. JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21. JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products. WARNINGS Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled PRECAUTIONS To minimize the risk of potential complications, these products should only be used by healthcare professionals who are knowledgeable about the anatomy and the product(s) for use in indicated area(s), and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications The potential risks of soft tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies The safety for use of these products in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied The safety for use during pregnancy and in breastfeeding females has not been established The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation, 22 and 80 years of age for chin augmentation, and 32 and 82 years of age for improvement of temple hollowing The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and the safety for use of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC, and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established Dermal filler implantation carries a risk of infection. Follow standard precautions Dermal fillers should be used with caution in patients on immunosuppressive therapy Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established The safety of using a cannula with JUVÉDERM® VOLUMA® XC for cheek augmentation in patients with Fitzpatrick Skin Types V and VI or to improve temple hollowing has not been established JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied Patients may experience late-onset adverse events with injectable gel implants, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (132 lb) body mass per year. The safety of injecting greater amounts has not been established Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied ADVERSE EVENTS The most common reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support at 1-877-345-5372. Please visit rxabbvie.com for more information. Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie 21% more press release views with Request a Demo

AbbVie's lawsuit is the latest in a string of Inflation Reduction Act-related legal complaints, but it mounts a unique argument centered on Botox's status as a plasma-derived product. In response to last month’s list of the 15 drugs chosen by the Centers for Medicare & Medicaid Services (CMS) for upcoming price cuts under the Inflation Reduction Act (IRA), AbbVie is the latest to join the flood of industry litigation over the law.While AbbVie’s lawsuit contends that the CMS pricing negotiations mandated for Botox step on the company’s constitutional rights—a common thread woven into much of the industry’s legal complaints about the program—the Illinois-based drugmaker also takes a unique position that specifically relates to the formulation of its offering. When the IRA was signed into law by former President Joseph Biden in 2022, the law made clear that only certain products are eligible to make the list of drugs that will go through negotiations to determine maximum fair prices paid under Medicare. The IRA specifically excludes “low-spend drugs,” or those with Medicare spending of less than $200 million, certain orphan rare disease drugs and plasma-derived products. AbbVie is hedging its argument around the IRA’s “express statutory exclusions” for plasma-derived products, it said in its complaint, which was filed in a Washington D.C. District Court on Feb. 11 and names the Department of Health and Human Services (HHS), CMS and their respective leaders, Robert F. Kennedy Jr. and Mehmet Oz, M.D.Botox is used commonly for cosmetic purposes but also holds therapeutic indications for chronic migraines, urinary incontinence and eye disorders such as blepharospasm (or uncontrolled eye blinking) and strabismus (crossed eyes). The drug is an injection that selectively blocks nerve activity to targeted muscles and is made from onabotulinumtoxinA (onabotA), human serum albumin (HSA), and sodium chloride.HSA is sourced from donated human blood plasma and is therefore vulnerable to supply-chain interruptions based on donor supply, according to the lawsuit. This factor, AbbVie says, was “implicitly acknowledged” by Congress when it specifically excluded plasma-derived products from IRA pricing controls.AbbVie further points to the stated purpose of the IRA’s drug pricing reform, which is to “lower prices for certain high-priced single source drugs,” the bill states. CMS clarified in a memorandum that it will "exclude plasma-derived products when identifying qualifying single source drugs,” defining a plasma-derived product as derived from human whole blood or plasma, as defined on its product labeling.The label for AbbVie’s Botox notes that it contains “a derivative of human blood.”As AbbVie puts it, the plasma aspect of its product is a central ingredient to the drug’s formulation and “directly contributes” to its therapeutic effects. Botox contains “approximately 100,000 more HSA than onabotA,” or, to put it another way, the equivalent of “onabotA occupying a single seat in the University of Michigan’s football stadium” while HSA takes up every other seat in the stadium, the company explained.The company was aware in 2025 that CMS may select Botox for its next list of drug price negotiations and sent “multiple emails and letters” explaining that the IRA’s plasma-derived exclusion prohibited the agency from including Botox on its list. However, CMS offered the company “no feedback” to this end and ultimately selected it for 2028 price cuts last month, with “no explanation for its failure to apply the statute’s plasma-derived exception to Botox,” AbbVie said in its suit.AbbVie’s complaint also claims violations of the Fifth and First Amendments, arguing that the negotiation program prohibits fair speech and takes private property for public use. These arguments have been levied by several other drugmakers in their own IRA lawsuits, most of which have fallen flat in the courts.  During AbbVie’s Feb. 4 earnings conference call, CEO Robert Michael alluded to the plasma-derived exception, expressing that the company is “obviously disappointed that [Botox] was selected given that it’s a plasma-derived product and should have been excluded.” However, the executive emphasized that Botox’s potential pricing negotiation does not have an impact on the company’s long-term growth guidance as it “did plan conservatively” in preparation for the selection.AbbVie picked up Botox through its 2019 acquisition of Allergan for $63 billion. In 2025, the company collected $3.76 billion in global sales for Botox’s therapeutic indications, while cosmetic Botox garnered $2.6 billion as the largest contributor to its aesthetics portfolio.Botox and the 14 other drugs selected for Medicare price negotiations together accounted for about $27 billion in prescription drug spending on Medicare between November 2024 and October 2025, CMS said when it announced the list on Jan. 27. The pricing negotiations for this round will take place this year, with the negotiated prices to take effect in 2028.