Health Canada approves Chiesi’s MYALEPTA for lipodystrophy

2024-02-06

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Health Canada approves Chiesi’s MYALEPTA for lipodystrophy

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来源: Pharmaceutical Technology

The safety and efficacy of the asset in treating metabolic disorders linked to lipodystrophy syndromes were evaluated in an open-label, single-arm study. Credit: MikeSaran / shutterstock.com.

Health Canada has approved Chiesi Group unit Chiesi Global Rare Diseases’ MYALEPTA (metreleptin for injection) to treat individuals with lipodystrophy, an ultra-rare condition.

MYALEPTA is a replacement therapy adjunct to diet to address complications of leptin deficiency in patients with congenital or acquired forms of the disease.

MYALEPTA can be used in adults and children aged two and above with confirmed congenital generalised lipodystrophy (Berardinelli-Seip syndrome) or acquired generalised lipodystrophy (Lawrence syndrome).

It is also approved for patients aged 12 years and above with familial partial lipodystrophy (PL) or acquired PL (Barraquer-Simons syndrome). The treatment is intended for patients with metabolic disease who have not achieved adequate metabolic control with conventional treatments.

MYALEPTA is originally developed by Amryt Pharma. Chiesi Group gained access to MYALEPTA through the acquisition of Amryt in April 2023.

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The safety and efficacy of the asset in treating metabolic disorders linked to lipodystrophy syndromes were evaluated in a long-term, open-label, single-arm study.

The research was conducted under the supervision of the US National Institutes of Health.

Weight decrease, hypoglycaemia and fatigue were the most commonly observed adverse drug reactions linked to the treatment.

Chiesi Group Global Rare Diseases head Giacomo Chiesi stated: “We are very proud of the partnership that we have developed with Medison and applaud the team for their efforts to bring this innovative and important treatment to patients in Canada.

“At the Chiesi Group, we are committed to creating a difference in the lives of patients with rare diseases and in collaboration with the Medison team, we have been able to achieve this for those living with lipodystrophy.”

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