Myalepta is indicated as a replacement therapy as an adjunct to diet to treat the complications of leptin deficiency in lipodystrophy patients of age 12 years and older
Health Canada approves Chiesi’s Myalepta. (Credit: CDC on Unsplash)
Chiesi Global Rare Diseases, a unit of the Chiesi Group, has secured Health Canada’s approval for Myalepta (metreleptin for injection) to treat patients with lipodystrophy (LD).
Myalepta is indicated as a replacement therapy as an adjunct to diet to treat the complications of leptin deficiency in LD patients.
It is intended for 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.
Additionally, Myalepta is approved for use in adults and children aged 12 and older diagnosed with confirmed familial partial lipodystrophy (PL) or acquired PL (Barraquer-Simons syndrome).
This applies to patients with persistent severe metabolic disease for which traditional treatments have not been able to establish acceptable metabolic control.
The approval was supported by results from a long-term study that evaluated the safety and efficacy of metreleptin in the treatment of metabolic disorders related to lipodystrophy syndromes in paediatric and adult patients.
In individuals with congenital or acquired generalised lipodystrophy (GL), the observed primary effectiveness outcomes comprised a change in HbA1c of -2.2% and a change in triglyceride percentage of -32.1% from baseline to month 12.
In the patients in the PL subgroup, the observed primary efficacy results were a drop in HbA1c of -0.9% and a change in triglycerides of -37.4% from baseline to month 12.
Myalepta was developed by Amryt Pharma, which was acquired in April 2023 by the Chiesi Group.
In 2021, Amryt Pharma entered into a distribution partnership in Canada for Myalepta with Medison Pharma Canada. Medison Pharma has similar partnerships for the drug in Israel.
The multiregional relationship between the parties continued even after Amryt’s acquisition by Chiesi Farmaceutici.
Chiesi Group global rare diseases head Giacomo Chiesi said: “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.”