Alkermes Submits NDA For Depression Candidate To The FDA

Alkermes plc (NASDAQ:ALKS) announced submission of a new drug application (NDA) to the FDA for its pipeline candidate, ALKS 5461. The NDA seeks an FDA approval for the candidate’s usage in the adjunctive treatment of major depressive disorder (MDD). If approved, this would be the first therapeutic option for patients with depression with a novel mechanism of action.

We remind investors that in October 2013, the FDA had granted a Fast Track status to ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to the standard antidepressant therapies. The Fast Track designation from the FDA facilitates the development and expedites the review of drugs that are intended to treat serious conditions and address medical needs.

Alkermes’ shares have underperformed the industry in a year’s time. The stock has gained 4.5% compared with the industry’s increase of 4.9%.

Notably, the NDA submission was supported by encouraging efficacy and safety data package from more than 30 clinical trials conducted on more than 1,500 patients with the aforementioned indication. The candidate has demonstrated antidepressant activity, safety and tolerability across all development programs.

In June 2017, the company initiated a phase IIIb study on MDD patients evaluating ALKS 5461. The subjects enrolled in the trial had earlier shown inadequate response to commonly prescribed depression drugs.

Per the company’s press release, around 17 million are annually diagnosed with MDD in the United States of which, a large number does not get sufficient relief from the first-line standard antidepressant therapy. Hence, approval of this drug will provide the company with access to a huge patient population base looking for a new treatment to apprehend this serious mental illness.

Allkermes’ revenues continue to be driven by proprietary products, Vivitrol and Aristada, and partnered products namely Johnson & Johnson’s (NYSE:JNJ) Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza/Trevicta, Acorda Therapeutics’ (NASDAQ:ACOR) Ampyra/Fampyra and AstraZeneca’s (NYSE:AZN) Bydureon.

Notably, the company’s progress with pipeline candidates targeting major CNS (central nervous system) disorders such as, schizophrenia, addiction, depression and multiple sclerosis, has been impressive. Successful development and subsequent commercialization of other interesting candidates like ALKS 3831 (phase III – schizophrenia), ALKS 8700 (phase III – multiple sclerosis) and ALKS 6428 (phase III – to help physicians transition patients from physical dependence on opioids to Vivitrol) would lend a huge boost to the company.

Zacks Rank

Alkermes carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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