AstraZeneca’s (AZN) Myalept has been approved by the U.S. Food and Drug Administration (FDA) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
The approval was in line with our expectations. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) had voted in favor of approving Myalept for the treatment of generalized lipodystrophy patients.
However, approval came with a boxed warning that with the use of Myalept, patients may develop anti-drug antibodies with neutralizing activity to the drug, which could result in severe infections or loss of optimum treatment benefit. Additionally, Myalept is contraindicated in patients with general obesity and not approved for use in patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.
Taking into account the risks associated with the use of Myalept, the drug will be distributed through a strict Risk Evaluation and Mitigation Strategy (REMS) program. The FDA has mandated seven post-marketing studies on Myalept (including a long-term prospective observational study of patients) and an assessment of spontaneous reports of potential side effects associated with Myalept. Furthermore, eight studies have been requested as post-marketing commitments.
The candidate enjoys orphan drug designation in both the U.S. and Europe.
We remind investors that AstraZeneca acquired full rights to Myalept from Bristol-Myers Squibb Company (BMY) as part of the acquisition of the diabetes alliance assets, completed on Feb 1, 2014.
We believe that the approval of Myalept for a narrower indication along with strict REMS would limit the drug's sales potential.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Auxilium Pharmaceuticals Ltd. (AUXL). Both carry a Zacks Rank #1 (Strong Buy).
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