Bristol-Myers, AstraZeneca get faster FDA review

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Associated Press

Posted on June 4, 2013 at 4:01 PM

NEW YORK (AP) — Bristol-Myers Squibb Co. and AstraZeneca PLC said Tuesday that the Food and Drug Administration will conduct an accelerated review of their lipid disorder drug metreleptin.

The companies want to market metreleptin as a treatment for metabolic disorders associated with rare forms of a condition called lipodystrophy, a disorder that affects the metabolism of fats. The FDA conducts faster reviews of some medications that can be used to treat a disease that has few or no therapeutic options.

The companies filed for FDA approval of metreleptin March 27 and expect the agency to take eight more months to review the drug.

The companies said lipodystrophy affects only a few thousand patients worldwide, and metreleptin has received orphan drug status in the U.S. and European Union. Orphan drug status is awarded to drugs that could treat very rare diseases, and it comes with additional marketing exclusivity.

Patients with lipodystrophy lose fat tissue, especially under the skin. That causes a deficiency of a hormone called leptin, and the leptin deficiency throws the body's system for regulating energy use and storage out of balance. As a result, lipids can build up in the liver and muscle, causing a variety of serious health problems.

Metreleptin is a version of leptin.

Bristol-Myers is based in Princeton, N.J., and AstraZeneca is based in the U.K.

Shares of Bristol-Myers lost 88 cents to $46.71 in afternoon trading, and AstraZeneca stock fell 34 cents to $51.15 as broader market indicators fell.

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