23rd Mar 2021 19:03
Amryt Pharma PLC - biopharmaceutical company - Receives positive feedback from the US Food & Drug Administration on the path forward for Myalept indication in partial lipodystrophy. Myalept is approved in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It is also approved in the EU.
Building on previous FDA interactions, Amryt has recently received additional feedback on the proposed development plan and study design to support an indication for patients with partial lipodystrophy. The FDA confirmed that it is willing to consider an efficacy supplement based on six-months efficacy and safety data from a randomized, placebo-controlled trial in partial lipodystrophy patients.
"We now have a very clear path forward for our global clinical study of metreleptin in partial lipodystrophy which, if successful, could offer the potential to address a broader population of patients in need," says Chief Executive Joe Wiley.
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By Evelina Grecenko; [email protected]
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