- Posted by ISPE Boston
- On May 2, 2018
Alkermes has announced that the FDA has accepted for review its New Drug Application (NDA) for ALKS 5461, a drug for the treatment of major depressive disorder (MDD) in patients who meet certain criteria. FDA’s acceptance of the NDA came just two weeks after the agency issued a Refusal to File letter and follows discussions in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to the FDA. FDA’s target action date for the NDA is January 31, 2019.
“FDA’s filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years,” stated Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. “We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients.”
Alkermes is a global biopharmaceutical company based in Dublin, Ireland with its U.S. headquarters in Waltham. The company’s focus is developing innovative medicines for the treatment of central nervous system (CNS) diseases. They have a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. (Source: Alkermes Website, 16 April, 2018)