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UPDATE: Alkermes Says FDA Stated Resolution Of Certain Conditions Related To The Tablet Coating Process At The Company's Wilmington Facility Is Required Before ALKS 3831 May Be Approved; CRL Did Not Identify Concerns About Clinical Or Non-Clinical Data

DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New

· 11/17/2020 07:05

DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder. Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved. The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

The observations noted in the CRL were specific to certain development batches of ALKS 3831. The company believes this issue has since been resolved and that sufficient data is available to address these observations. Alkermes is preparing those data for submission and plans to work closely with the Agency to resolve these items in a timely manner and complete labeling discussions for the application.

Consistent with FDA's August 2020 Guidance for Industry related to manufacturing inspections during the COVID-19 global pandemic, the Agency did not conduct an on-site Pre-Approval Inspection (PAI) at the company's Wilmington, OH manufacturing facility during its review of the NDA, and instead conducted a remote review of records under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. FDA confirmed receipt of the requested records provided by Alkermes on Sept. 11, 2020 and, since that date, no report or feedback from this records review was provided to Alkermes until receipt of the CRL.

"We will continue to work closely with the Agency in an expeditious manner to support approval of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder and believe we have a clear path to resolution. Importantly, there were no clinical issues identified in the CRL pertaining to ALKS 3831's efficacy or safety, and no new studies were requested for approval of the application," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

The NDA submission for ALKS 3831 was based on data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone, and pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA®. Throughout the clinical development program, ALKS 3831 demonstrated a consistent antipsychotic efficacy, safety, and tolerability profile in patients with schizophrenia.

In October 2020, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee appointed by the FDA jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes, 3 no, 1 abstention). The committees also jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan (11 yes, 6 no).