Alkermes Gets FDA Nod for Two Month Dose of Aristada

Alkermes plc ALKS announced that the FDA has approved two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. The new two month dose is expected to be available in mid-June.

Alkermes' share price increased 6.1% year to date outperforming the Zacks classified Medical - Biomedical and Genetics industry's gain of 1.7%.

Consequently, Aristada  is now approved in four doses and and three dosing duration options (441 mg, 662 mg or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months).

As a result, Aristada provides a number of options to help clinicians tailor treatment to the individual needs of their patients.  The drug was originally approved in Oct 2015.

We note Aristada posted sales of $18 million in the first quarter of 2017, up compared with $5.6 million in the first quarter of 2016. Aristada is growing impressively in a long-acting injectable (LAI) market, evident from its improvement in the double digits.

However, in Mar 2017, Allergan plc AGN announced that its supplemental New Drug Application (sNDA) Vraylar has been accepted for review by the FDA. Allergan is looking to get Vraylar's label expanded to include new data, which supports the drug's use as a maintenance treatment.

Alkermes PLC Price

 

Alkermes PLC Price | Alkermes PLC Quote

Zacks Rank and Stocks to Consider

Alkermes carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector includes VIVUS, Inc. VVUS and MEI Pharma, Inc. MEIP, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

VIVUS' loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in the trailing four quarters, with an average beat of 233.69%.

MEI Pharma's estimates narrowed from loss per share of 1 cent to gain per share of 1 cent for 2017 in the last 30 days. The company posted positive earnings surprises in three of the four preceding quarters, with an average beat of 66.56%.

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