Sanofi Gets CDSCO Nod for Qfitlia, a New Haemophilia Therapy Requiring Just 6 Injections a Year
New Delhi: Sanofi Healthcare on Wednesday said it has received marketing authorisation from drug regulator CDSCO for Qfitlia, a therapy used to prevent bleeding in haemophilia patients.
The approval from the Central Drugs Standard Control Organiation (CDSCO) covers adults and adolescents aged 12 years and older, with or without factor VIII or IX inhibitors, Sanofi Healthcare India Pvt Ltd said in a statement.
"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," said Parwas Mahajan, Business Head, Rare Diseases, Sanofi (India).
Qfitlia (Fitusiran) is a therapy used for routine prophylaxis to prevent or reduce bleeding episodes in patients with haemophilia A or B, the Indian arm of the French multinational pharmaceutical company Sanofi SA said.
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, that can result in permanent damage and disability.
The approval is based on data from the ATLAS phase 3 clinical development programme, which showed clinically meaningful bleed protection across patients, the release added.
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