The USFDA has granted priority review designation for investigational agent Metreleptin, jointly developed by Bristol-Myers Squibb Company and AstraZeneca, for the treatment of metabolic disorders associated with rare forms of lipodystrophy.
Investigational recombinant analog of the human hormone leptin, Metreleptin is being assessed for the treatment of metabolic disorders coupled with inherited or acquired lipodystrophy.
Bristol-Myers CV and Metabolics development head, senior vice president Fred Fiedorek said, "Developing metreleptin for the treatment of lipodystrophy demonstrates Bristol-Myers Squibb and AstraZeneca's continued dedication to scientific innovation and global patient care for people impacted by diabetes and related metabolic disorders."
The primary data from ongoing National Institutes of Health (NIH) trial in adult and pediatric patients with inherited or acquired LD is included in the biological license application.
