Novelion Therapeutics Inc. announced that the European Commission (EC) has granted 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 in adults and children 2 years of age and above; or with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. MYALEPTA, a recombinant analog of human leptin, is the first and only licensed treatment in Europe indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in LD patients. The clinical data supporting the authorization resulted from an open-label, single-arm study evaluating MYALEPT treatment in 48 patients. In accordance with the receipt of a marketing authorization under exceptional circumstances, certain risk minimization measures and post-authorization obligations will be required, including proposed studies which will further the understanding of MYALEPTA impact on patients with generalized and partial lipodystrophy.