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FDA grants metreleptin BLA priority review designation

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The FDA has granted priority review designation for the Biologics License Application for metreleptin — an investigational recombinant analogue of human leptin, according to a press release.

The drug is indicated for the treatment of metabolic disorders associated with lipodystrophy. According to data recently presented at the Pediatric Academic Societies Annual Meeting, patients (aged 12 to 18 years) administered metreleptin 4.4 mg (Bristol-Myers Squibb and AstraZeneca) subcutaneously once or twice daily for a mean duration of 3.9 years demonstrated significantly decreased HbA1c and triglycerides.

This priority status indicates that the agency will aim to complete the review process within 8 months.

For more information:

Brown R. #3490.3. Presented at: Pediatric Academic Societies Annual Meeting; May 4-7, 2013; Washington.

Clinicaltrials.gov, NCT00677313. Accessed June 4, 2013.