Levodopa hydrate

After being rejected by the US Food and Drug Administration (FDA) over a year ago, the world's leading biopharmaceutical company AbbVie did not give up, but instead tried to launch a revolutionary Parkinson's disease drug, ABBV-951, again, aiming to provide patients with a more convenient treatment option to replace their current carbidopa and levodopa formulation. However, the FDA's rejection has brought new challenges and tests for AbbVie.   The FDA's complete response letter (CRL) detailed the observations made during the inspection of third-party manufacturers for AbbVie's drug application. Although AbbVie stressed that these factories' inspections did not involve ABBV-951 or any of AbbVie's drugs, the FDA's decision undoubtedly cast a shadow over this highly anticipated new drug.   AbbVie's forward-looking therapy is a combination of foscarbidopa and foslevodopa, which are the precursors of carbidopa and levodopa, respectively, included in AbbVie's Parkinson's treatment drug Duopa, approved in 2015. Precursors, as a special form of drugs, enter the body and are converted into active drug components once inside. This design aims to improve the drug's bioavailability and reduce side effects, providing better treatment outcomes for patients. Despite the FDA's rejection, which left AbbVie deeply disappointed, the company has not given up on its collaboration with the FDA and continues to advance the development of ABBV-951. AbbVie Senior Vice President and Global Therapy Chief Medical Officer Dr. Roopal Thakkar stated in a statement, "We will continue to work closely with the FDA to address the current issues and strive to bring ABBV-951 to market as soon as possible."   The FDA's rejection did not involve the safety, effectiveness, or labeling issues of ABBV-951, including the drug's subcutaneous pump device. In the past, this device did give some pharmaceutical companies trouble, but AbbVie has conducted thorough research and validation to ensure its safety and effectiveness.   Last March, ABBV-951 was rejected by the FDA for the first time, due to the need for additional information about the candidate drug's delivery device. However, AbbVie did not give up, but instead made comprehensive improvements and supplements in response to the FDA's requirements. Today, ABBV-951 is delivered through a pump under the skin, providing patients with a more convenient and comfortable treatment option.   Evercore ISI analysts have high hopes for ABBV-951 and praised it as one of AbbVie's "biggest new products to launch in the next one to two years." Analysts believe that ABBV-951's design is intended to provide convenience advantages over Duopa, which has been on the market for nearly a decade in a gel form and must be administered via a feeding tube. This new method of drug delivery will greatly reduce the burden on patients and improve their quality of life. However, AbbVie stated in its press conference on Tuesday that it would not conduct any additional efficacy or safety trials for the candidate drug or its delivery device. This decision has drawn widespread attention from the industry, but AbbVie's confidence and determination in its products has not wavered.   Wall Street analysts had previously estimated that ABBV-951's peak sales could reach $1 billion, but the Evercore team said last year that they "would not be surprised" if the drug ultimately exceeded the $2 billion mark. This is enough to demonstrate the industry's expectations and confidence in ABBV-951.   Meanwhile, AbbVie's Parkinson's disease prodrug combination is also facing challenges from competitors. Mitsubishi Tanabe Pharma's nd-0612 is also a continuous subcutaneous infusion of liquid levodopa and carbidopa, and the Japanese company acquired NeuroDerm for $1.1 billion in 2017. However, Mitsubishi Tanabe revealed in a recent filing that nd-0612 had also been subject to an FDA CRL attack earlier this month. The details behind the rejection are scarce, but the company said it would review the complete response and work with the FDA to address the regulator's concerns.   In other areas, the pump-based therapy has also posed problems for other pharmaceutical companies developing Parkinson's disease drugs. For example, in April this year, Supernus' SPN-830 application was rejected for the third time due to product quality and syringe master file issues. These problems indicate that while new modes of administration offer convenience and comfort to patients, they also bring new challenges and tests.   Although AbbVie encountered setbacks in the development of ABBV-951, the company has not given up its exploration and innovation in Parkinson's disease treatment. AbbVie will continue to work with the FDA to advance the development and marketing of ABBV-951, bringing better treatment outcomes and quality of life to patients. At the same time, AbbVie will also keep track of its competitors' dynamics and market changes, continuously adjust and optimize its product line to maintain its leading position in Parkinson's disease treatment.

The agency’s complete response letter flagged observations discovered during an inspection of a third-party manufacturer listed in AbbVie’s drug application. The inspection at the facility did not involve ABBV-951 or any AbbVie medicine, the drugmaker stressed. A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa. The U.S. Food and Drug Administration (FDA) has once again rejected AbbVie’s ABBV-951 for controlling motor fluctuations in patients with advanced Parkinson’s disease, the company said Tuesday. The agency’s complete response letter (CRL) flagged observations discovered during an inspection of a third-party manufacturer listed in AbbVie’s drug application. The inspection at the facility did not involve ABBV-951 or any AbbVie medicine, the drugmaker stressed. AbbVie’s prospective therapy is a combination of foscarbidopa and foslevodopa, which are the respective prodrugs for the carbidopa and levodopa included in AbbVie’s 2015-approved Parkinson’s treatment Duopa. Prodrugs are versions of medications that become active once they enter the body. Despite the rejection, AbbVie remains committed to working with the FDA to bring ABBV-951 forward, Roopal Thakkar, M.D., SVP, and chief medical officer of global therapeutics at the company, said in a statement. The FDA’s rebuff did not flag any issues related to the safety, efficacy or labeling of AbbVie’s drug candidate, including the combination’s subcutaneous pump device, which has caused problems for the drugmaker in the past. Last March, ABBV-951 was rejected because the FDA needed additional information about the candidate’s delivery device. ABBV-951, which analysts at Evercore ISI have hailed as one of AbbVie’s “biggest new product launches over the next year or two,” is designed to offer a convenience edge over the nearly decade-old Duopa, which comes in a gel form and must be administered orally with a pump through a stomach tube. ABBV-951, for its part, is given continuously under the skin via a pump. AbbVie added in its Tuesday press release that it’s not on the hook to run any additional efficacy or safety trials related to the drug candidate or its delivery device. Previously, Wall Street analysts projected ABBV-951’s peak sales could reach $1 billion, though the Evercore team last year said it “wouldn’t be surprised” if the drug eventually surpassed the $2-billion mark. Meanwhile, AbbVie’s prodrug Parkinson’s combo could eventually face competition in the form of Mitsubishi Tanabe Pharma’s ND-0612—also a continuous subcutaneous infusion but of liquid levodopa and carbidopa—which the Japanese company acquired in its $1.1-billion acquisition of NeuroDerm in 2017. Thankfully for AbbVie, ND-0612 was also hit with a CRL earlier this month, Mitsubishi Tanabe revealed in a recent filing. Details on the rationale behind the rejection were slim, with the company simply noting that it would review the complete response and work with the FDA to address the regulator’s comments. Elsewhere, infusion pump-based therapies have posed problems for other drugmakers developing Parkinson’s disease drugs, too. Look no further than Supernus, which in April received a third rejection of its prospect SPN-830 tied to product quality and the drug’s infusion device master file.   At the time, Supernus said it had submitted product quality data that the FDA had yet to review, adding that it planned to discuss requested information and steps to resubmit the master file for the delivery technology with the FDA. The rejection came after the FDA wrapped up a successful pre-approval inspection of the device manufacturer’s facility in February. Supernus was not deterred and remains “committed to bringing SPN-830 to the market,” CEO Jack Khattar said in a statement earlier this year. “We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA.”