The COVID-19 pandemic has changed the way the pharmaceutical industry works, crucially in how regulators inspect key manufacturing sites. To skirt around lockdowns, the FDA has started conducting "remote reviews" for new drug applicants—and investigators from afar are proving to be a tough nut to crack.
The FDA sent back Alkermes' application for controversial schizophrenia and bipolar disorder drug ALKS 3831 after finding tablet coating issues during a remote review of the biotech's manufacturing site in Wilmington, Ohio, Alkermes said Tuesday.
In a complete response letter, the FDA required Alkermes to resolve those issues before reapplying for approval, Alkermes said. Alkermes believes the FDA's concerns were related to specific development batches of the drug and have already been resolved, the company said in a release.
Alkermes noted the FDA's letter did not present any new issues with the ALKS 3831's safety or clinical data.
The FDA conducted a remote review at the Wilmington, Ohio site in keeping with its August guidance to seek alternative ways to conduct planned walkthroughs at manufacturing plants. Alkermes submitted the review documents by Sept. 11 and said it hadn't received feedback from the FDA before getting the letter in the mail.
ALKS 3831 has already had a rocky road to approval with a contentious FDA advisory committee in October casting doubts on the drug's side effects on patients already treated with opioids.
The drug is a combination of olanzapine, the active ingredient of Eli Lilly's Zyprexa, with samidorphan, an opioid antagonist designed to counter the weight gain and metabolic side effects of Lilly’s antipsychotic.
In October, the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-1 that Alkermes showed samidorphan “meaningfully mitigates” weight gain linked to olanzapine, and 13-3—with one panelist abstaining—that the company “adequately characterized” the drug’s safety profile.
The committee noted, however, that samidorphan might affect patients taking opioids like morphine or oxycodone, potentially causing a reduced painkilling effect in patients taking opioids, withdrawal symptoms in patients dependent on opioids and opioid overdose.
Alkermes planned to tackle those issues in the drug’s labeling, and the panel voted a more narrow 11-6 that Alkermes' labeling plans were enough to address the potential health risks.