Alkermes plc (Alkermes) recently announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for ALKS 5461. ALKS 5461 is the pharmaceutical company’s adjunctive treatment for major depressive disorder (MDD).
The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form, and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL, as well as potential next steps for ALKS 5461. The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 individuals with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety, and reliability in the treatment of MDD.
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, and multiple sclerosis.
This was reported by Alkermes on February 1, 2019.
Contact Information: Alkermes plc, 852 Winter Street, Waltham, Massachusetts 02451; (781) 609-6000; Website: www.alkermes.com