Alkermes pulls MAA for Megestrol product

13 March 2012

The European Medicines Agency says it has been formally notified by the Irish subsidiary of US drugmaker Alkermes (Nasdaq: ALKS) of its decision to withdraw its application for a centralized marketing authorization for the medicine Megestrol Alkermes (megestrol), 125mg/ml oral suspension. Megestrol Alkermes was intended to be used for the treatment of anorexia, cachexia or an unexplained significant weight loss in adult AIDS and oncology patients.

The marketing authorization application (MAA) for Megestrol Acetate was submitted to the Agency by Alkermes Pharma Ireland on December 11, 2009. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that it had decided to withdraw the application as a consequence of portfolio prioritization.

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