MYALEPTA® (metreleptin) Receives Positive CHMP Opinion in Patients with Generalized and Partial Lipodystrophy
NOVELION THERAPEUTICS INC COMMON SHARES (NVLN)
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Source: GlobeNewswire
Europe represents potentially the largest market for metreleptin with expected authorization in both generalized and partial lipodystrophy VANCOUVER, British Columbia, June 01, 2018 (GLOBE NEWSWIRE) -- Novelion Therapeutics Inc. (NASDAQ:NVLN), a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorization, under exceptional circumstances, for MYALEPTA. The CHMP recommends granting marketing authorization for MYALEPTA, as an adjunct to diet, as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients with confirmed congenital generalized LD (Berardinelli-Seip syndrome); or acquired generalized LD (Lawrence syndrome) in adults and children 2 years of age and above; or with confirmed familial partial LD or acquired partia
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