plc (ALKS 45.98, +3.45, +8.11%) is trading higher today after announcing some positive news
that the FDA has accepted ALKS 5461 for review, its medicine for the adjunctive
treatment of major depressive disorder (MDD) in patients with an inadequate
response to standard antidepressant therapies.
MDD is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational, or other typical behaviors. An estimated 16.2 mln people in the US suffered from MDD in 2016, the majority of whom may not adequately respond to initial antidepressant therapy. ALKS 5461 is intended for the adjunctive treatment of major MDD in patients with an inadequate response to standard antidepressant therapies.
In case you're not familiar, Alkermes is a major biopharma company that focuses on developing drugs that treat central nervous system (CNS) 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.
It hasn’t been smooth sailing for ALKS 5461. In fact, the company's stock sold off in early April when the company announced it had received a Refusal to File letter from the FDA regarding its New Drug Application (NDA) for ALKS 5461. The FDA said it was unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461.
The FDA has now rescinded its Refusal to File letter and has accepted the ALKS 5461 NDA. Since the initial Refusal to File letter, Alkermes has been working closely with the FDA to address any concerns. Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to the FDA.
The NDA filing for ALKS 5461 is based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety, and tolerability.
In sum, investors are clearly happy to see the NDA finally being accepted by the FDA and it was very good that Alkermes did not have to submit additional data or analyses. It basically needed to clarify items in the NDA and enough was done so that the FDA has now accepted the NDA. Keep in mind, this is not a final approval, but it is a key milestone for this drug hopefully getting approved. Looking ahead, the FDA's target action date for the NDA is January 31, 2019.
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