Chiesi Global Rare Diseases Announces Health Canada Approval of MYALEPTA™ (metreleptin for injection) for the Treatment of Patients with Lipodystrophy

"MYALEPTA Health Canada Approval"

 Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, is pleased to announce the Health Canada approval of MYALEPTA™ (metreleptin for injection).

As an adjunct to diet, MYALEPTA is indicated as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children two years of age and above. MYALEPTA is also indicated in adults and children 12 years of age and above with confirmed familial partial LD (PL) or acquired PL (Barraquer-Simons syndrome) with persistent significant metabolic disease for whom standard treatments have failed to achieve adequate metabolic control.

MYALEPTA was developed by Amryt Pharma, which was acquired in April 2023 by the Chiesi Group, an international, research focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare disease and specialty care.

“Patients living with lipodystrophy are often burdened with tremendous physical, psychological and emotional challenges and as a profession we have had little in our toolbox of treatments to help them,” said Dr. Robert A. Hegele, Endocrinologist, Professor of Medicine and Biochemistry, Western University. “The approval of MYALEPTA provides clinicians and patients with a treatment that directly impacts the underlying metabolic disorder, which will result in effective symptom control.”

“We are very pleased that Medison has taken the initiative needed to secure MYALEPTA’s approval in Canada, offering patients new hope with a treatment specifically targeting the underlying cause of this rare condition,” said Dr. Sonia Rehal, science educator and patient advocate, Lipodystrophy Canada Foundation. “Being a lipodystrophy patient myself and having lost my mother and sister to complications from this devastating disorder, our work is helping to advocate on behalf of patients and caregivers.”


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