The U.S. Food and Drug Administration (FDA) has contacted Alkermes regarding the company’s new drug application for ALKS 3831 that treats adults with schizophrenia and bipolar I disorder.
Following a remote review of manufacturing records, the FDA stated that resolution of certain conditions related to the tablet coating process at the company’s Wilmington facility is required before ALKS 3831 may be approved, according to an Alkermes media release.
The FDA’s letter did not identify or raise any concerns about the clinical or non-clinical data in the new drug application. Also, the FDA has not asked Alkermes to complete any new clinical trials to support approval, the media release stated.
The FDA’s observations were specific to certain development batches of ALKS 3831, the release said.
“The company believes this issue has since been resolved and that sufficient data are available to address these observations. Alkermes is preparing those data for submission and plans to work closely with the [FDA] agency to resolve these items in a timely manner,” the release stated.
Compliant with the FDA’s August 2020 Guidance for Industry related to manufacturing inspections during the COVID-19 pandemic, the FDA did not conduct an on-site pre-approval inspection at the company’s Wilmington manufacturing facility during its review of the new drug application, the company stated.
The FDA instead conducted a remote review of records.
Alkermes’ new drug application submission for ALKS 3831 was based on data from 27 clinical studies, stated the media release.