Peanut (Arachis hypogaea) Allergen Powder-dnfp

DBV Technologies said its peanut allergy patch succeeded in a Phase 3 trial, setting the company up for another FDA submission after a drawn-out saga with regulators. The trial enrolled more than 650 children ages 4 to 7. Of those who received DBV’s Viaskin patch, 46.6% met the trial’s responder criteria, measured by the amount of children who could be exposed to a certain amount of peanut protein at month 12 without having an allergic reaction. In the placebo group, 14.8% of kids met the responder criteria, according to the topline data. For patients who could tolerate up to 30 mg of peanut protein at baseline, the goal was for them to be able to tolerate at least 300 mg at the one-year mark. For patients who could tolerate 100 mg at baseline, the goal was to get them to at least 600 mg at one year. One peanut kernel is about 250 mg to 300 mg, DBV’s CMO Pharis Mohideen estimated. “The levels of desensitization achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into pediatric care,” the study’s principal investigator David Fleischer said in a news release. DBV said it plans to file for FDA approval in the 4 to 7 age group in the first half of 2026. The company initially filed for approval in 4- to 11-year-olds in 2018, but withdrew its application after regulators asked for more information on manufacturing and quality controls. It resubmitted its application in 2019, but received a complete response letter in 2020. Upon rejecting the drug, the FDA raised concerns about whether the patch was adhesive enough, and whether that affected the efficacy of the product. Regulators asked DBV to modify the patch and provide new clinical data. They also requested more chemistry, manufacturing and controls data. The company has since changed the size and shape of the patch, which is intended to be applied once a day. It also decided to narrow the age group, because after evaluating data in children up to 11 years old, the younger group responded better to treatment. “We felt that was where we could have the biggest impact and meet the highest unmet medical need,” Mohideen told Endpoints News in an interview. DBV secured up to $306 million in financing earlier this year to help support its FDA submission and potential launch. DBV’s longtime competitor is Aimmune, whose allergy pill Palforzia became the first approved peanut allergy treatment in 2020. Nestlé snatched up the pill in its $2.6 billion acquisition of Aimmune later that year, then divested the drug to Stallergenes Greer in 2023. But Stallergenes Greer announced it will stop commercializing Palforzia on July 31, 2026. Roche and Novartis’ injectable treatment Xolair was also approved to treat food allergies in 2024. But DBV is confident in the product profile of its patch. The company is also vying for an accelerated approval in 1- to 3-year-old patients with the original shaped patch. “​​The product profile that we have is so different. Our product is non-invasive,” Mohideen said. For many parents, he said “that’s an absolute showstopper.” DBV said on Tuesday that the new safety results were in line with the drug’s original safety data. The most common adverse events that arose during treatment were mild-to-moderate skin reactions at the patch application site. Treatment-related anaphylaxis occurred in two children, but both cases were resolved and the children remained on treatment. One of the children required a single dose of epinephrine.

LENOIR, N.C.--(BUSINESS WIRE)--Stallergenes Greer, a global leader in allergy therapeutics, today announced that a new segment of “The Balancing Act®” airing on Lifetime TV featured its product Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first and only U.S. Food and Drug Administration (FDA) approved oral immunotherapy treatment (OIT) for peanut allergy in children ages 1 through 17 years.1 The Stallergenes Greer sponsored segment premiered nationwide on Wednesday, July 30 at 7:30 a.m. (ET/PT) and features the story of a family with a peanut allergic child who was treated with Palforzia® . “We are proud to see Palforzia® featured on “The Balancing Act®,” bringing national visibility to peanut allergy and a first of it’s kind, FDA-approved oral immunotherapy treatment option for children and toddlers that can help to reduce the risk of life-threatening reactions that can occur with a peanut allergy,” said Tibor Nemes, Executive Vice President, Head of Americas for Stallergenes Greer. “This segment is an opportunity to educate patients, caregivers and healthcare providers about Palforzia®, and to further our commitment as Stallergenes Greer to provide innovative allergen immunotherapy (AIT) treatments to the allergy community that we serve.” Peanut allergy currently affects approximately 2% of the US pediatric population2-3 Compared to other food allergies, peanut allergy is associated with higher rates of morbidity due to accidental exposure4. The severity of reactions in some patients despite strict allergen avoidance efforts highlights the need for safe and effective therapies.5 The featured segment included insights shared by Pediatric Allergist and Immunologist, Panida Sriaroon, M.D., on food allergies and the challenges that some patients with food allergies and their families may face. Dr. Sriaroon, also presented Palforzia® and its significance as the first and only FDA-approved oral immunotherapy treatment option available in the treatment landscape for peanut allergy. Palforzia® was first approved by the FDA in 2020, under Aimmune Therapeutics, Inc., as an oral immunotherapy treatment (OIT) for the mitigation of allergic reactions, including anaphylaxis that may occur with accidental exposure to peanut in children ages 4 through 17 years. In 2024, the FDA approved Palforzia® for the expanded indication for toddler patients (ages 1 through 3 years) and the toddler product was launched in March 2025 by Stallergenes Greer. In addition to the July 30 premiere, the featured segment on “The Balancing Act” will be rebroadcast on Thursday, July 31, at 7:30 a.m. (ET/PT). It can also be viewed on the show’s website TheBalancingAct.com. Palforzia® is only available through a REMS (Risk Evaluation and Mitigation Strategy) program. Additional information about Palforzia®, including Boxed Warning, full Prescribing Information and Medication Guide is available at www.Palforzia.com. *The participants featured in this segment were compensated for their time. ABOUT PALFORZIA® Palforzia® is an oral immunotherapy treatment indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia® is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 1 to 17 years. Up-Dosing and Maintenance may be continued in patients 1 year of age and older. Palforzia® is to be used in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis. Palforzia® is approved by the U.S. Food and Drug Administration (FDA) for ages 1 through 17 years. IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS: Palforzia® can cause anaphylaxis, which may be life-threatening and can occur at any time during Palforzia® therapy. Prescribe epinephrine, instruct and treat patients on its appropriate use, and instruct patients to see immediate medical care upon its use. Do not administer Palforzia® to patients with uncontrolled asthma. Dose modifications may be necessary following a anaphylactic reaction. Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dose level, for at least 60 minutes. Palforzia® is available only through a restricted program called the Palforzia® REMS. CONTRAINDICATIONS: Palforzia® is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal diseases. WARNINGS AND PRECAUTIONS: Anaphylaxis: Palforzia® can cause anaphylaxis, which may be life-threatening. Palforzia® is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia® REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer Palforzia®. Anaphylaxis has been reported during all phases of Palforzia® dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures. Do not initiate Palforzia® treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. Palforzia® may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including, but not limited to, markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, Palforzia® may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine. All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered under observation in a certified healthcare setting. Patients may be more likely to experience allergic reactions following Palforzia® administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding Palforzia® temporarily. Asthma: Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of Palforzia®. Palforzia® should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of Palforzia® should be undertaken cautiously. Re- evaluate patients who have recurrent asthma exacerbations and consider discontinuation of Palforzia®. Eosinophilic Gastrointestinal Disease: Discontinue Palforzia® and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain. Gastrointestinal Adverse Reactions: Gastrointestinal adverse reactions were commonly reported in Palforzia®-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms, consider a diagnosis of eosinophilic esophagitis. IMPORTANT SAFETY INFORMATION (Continued) ADVERSE REACTIONS: The most common adverse reactions reported in subjects ages 1 through 3 years treated with Palforzia® (incidence ≥5%) are cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritus, and perioral dermatitis. The most common adverse reactions reported in subjects ages 4 through 17 years treated with Palforzia® (incidence ≥5% and at least 5% greater than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, urticaria, anaphylactic reaction, and ear pruritus. ABOUT THE BALANCING ACT The Balancing Act® is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime® and find all previously aired episodes on TheBalancingAct.com. ABOUT STALLERGENES GREER Headquartered in Baar (Switzerland), Stallergenes Greer is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergen immunotherapy products and services. Supported by more than 100 years of expertise and innovation, our products are available for patients in over 40 countries. For more information, visit www.stallergenesgreer.com. 1 PALFORZIA [package insert]. Lenoir, NC; Greer Laboratories, Inc. 2 Bilaver LA, Chadha AS, Doshi P, O’Dwyer L, Gupta RS. Economic burden of food allergy: A systematic review. Ann Allergy Asthma Immunol 2019;122:373–80 e1. 3 Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics 2011;128:e9–17. 4 The global burden of illness of peanut allergy: A comprehensive literature review. Jay A. Lieberman, Ruchi S Gupta, Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P. Mack, and Guillaume Pouessel. Online: https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC8247890/. Accessed August 31, 2023 5 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3. Accessed August 31, 2023. © 2025 Stallergenes Greer, Société des Produits Nestlé S.A. or its affiliates