Datapoint: FDA Nixes AbbVie’s New Parkinson’s Drug

The FDA last week rejected AbbVie’s drug application for ABBV-951 (foscarbidopa/foslevodopa), a treatment for motor fluctuations in adults with advanced Parkinson’s disease. While the agency did not ask AbbVie to conduct additional safety and efficacy trials, they are seeking additional information about the drug’s subcutaneous pump device. AbbVie, meanwhile, said it plans to resubmit the application as soon as possible. According to Evaluate Pharma, 2022’s top-selling in the Parkinson’s space was Acadia Pharmaceuticals’ Nuplazid, which brought in $517 million in worldwide sales. Nuplazid is specifically approved to treat Parkinson’s psychosis, and holds covered or better status for 94% of all insured lives under the pharmacy benefit. Coverage often requires prior authorization and/or step therapy.

From Evaluate Pharma and MMIT Analytics, as of 3/22/23

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