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FDA Grants Priority Review Designation For BLA For Metreleptin

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Bristol-Myers Squibb Company (BMY) and AstraZeneca (AZN.L,AZN) announced that the U.S. FDA has granted a Priority Review designation for the Biologics License Application for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy.

The FDA grants Priority Review to medicines that may provide a treatment option where little or no adequate therapy exists.

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to research, develop and commercialize select investigational drugs for type 2 diabetes. The expanded Bristol-Myers Squibb/AstraZeneca collaboration covers the co-development and marketing of products in the Amylin Pharmaceuticals portfolio, including, among others, investigational metreleptin.

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