Myalept (metreleptin) filed with EMA for leptin deficiency in patients with congenital or acquired generalized lipodystrophy- Novelion Therapeutics
Novelion Therapeutics announced that the European Medicines Agency has accepted for review the Marketing Authorization Application for Myalept (metreleptin) as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy and in a subset of patients with partial lipodystrophy. The MAA was filed in December 2016. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in December of 2017, and decision is expected in the first quarter of 2018.
Comment: The company, through a subsidiary, will seek to market metreleptin in the EU, if approved, under the tradename MYALEPTA.
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