Sanofi healthcare receives CDSCO approval for Qftilia therapy for haemophilia patients in India

Multinational pharmaceutical company, Sanofi Healthcare announced on Wednesday that it has received authorisation from drug regulator Central Drugs Standard Control Organisation (CDSCO) for Qfitlia, a therapy used to prevent bleeding in haemophilia patients.

According to the statement released by the company, the approval from the regulator covers adults and adolescents aged 12 years and older, and older, with or without factor VIII or IX inhibitors.

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“Qfitlia, with its unique ability to protect both those living with Haemophilia A and Haemophilia B (with or without inhibitors) with as few as six injections a year, has the potential to significantly expand access to prophylaxis in India," Parwas Mahajan, Business Head, Rare Diseases, Sanofi (India), said.

Qfitlia (Fitusiran) is a medical treatment used for routine prophylaxis to prevent or reduce episodes of bleeding in patients with haemophilia A or B, the company said.

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Haemophilia A and B are rare, congenital, lifelong bleeding disorders in which the blood's ability to clot is severely impaired, leading to excessive and spontaneous bleeds, particularly into joints, which can result in permanent damage and disability.

According to the release, the approval was based on the ATLAS phase 3 clinical development programme, which showed clinically meaningful protection against bleeding across patients.

(With inputs from PTI)