Manufacturing issues delay AbbVie's Parkinson's drug

AbbVie's potential treatment for Parkinson's disease, ABBV-951 (foscarbidopa/foslevodopa), has encountered another obstacle, as the FDA has issued a second complete response letter (CRL) for the drug in just over a year. This latest CRL pertains to manufacturing issues involving a third-party facility rather than the drug itself.

ABBV-951 is designed to address motor fluctuations in adults with advanced Parkinson's disease through a 24-hour continuous subcutaneous infusion of carbidopa and levodopa prodrugs. Neurologists have considered it a less invasive and cumbersome alternative to AbbVie's existing Duopa/Duodopa product, which requires an intraduodenal infusion.

In an update, AbbVie clarified that the FDA's concerns are unrelated to ABBV-951's safety, efficacy, or labeling, nor did the agency request additional clinical trials. The issues were discovered during an inspection of a third-party manufacturing facility involved in the new drug application. AbbVie emphasized that the inspection did not concern ABBV-951 or any of its other medications.

Last year in March, the FDA had already declined to approve the application, asking for more information about the infusion pump. According to Roopal Thakkar, AbbVie's chief medical officer of global therapeutics, there remains a significant unmet need for advanced Parkinson's disease treatments in the U.S. Thakkar stated that the company is committed to working with the FDA to make this important therapy available to patients as soon as possible.

ABBV-951 has already been approved in 34 countries, with over 2100 patients worldwide starting treatment. The therapy has generated significant interest in the medical community, with analysts predicting sales of $620 million by 2026 and $1.3 billion by 2028.

This development comes at a time when AbbVie is experiencing an unexpected surge in growth. Despite losing exclusivity for its blockbuster drug Humira (adalimumab) and the recent departure of its founding CEO, the company’s stock price has been rising. AbbVie's market cap recently surpassed that of Merck & Co., making it one of the more successful pharmaceutical companies this year.