According to MannKind Corporation, the Indian Central Drugs Standard Control Organization (CDSCO) has approved a marketing application submitted by Cipla for Afrezza inhaled dry powder insulin for the treatment of diabetes in adults. Cipla acquired the rights to market Afrezza in India in a deal signed in 2018.
Afrezza has been approved in the US since 2014 and in Brazil since 2019. MannKind recently announced that a Phase 4 trial of the DPI in Type 1 diabetics met its primary endpoint.
MannKind CEO Michael Castagna commented, “Achieving approval for Afrezza in India, a country with the second highest burden of diabetes worldwide, is an exciting milestone for MannKind and our partner Cipla. We are excited for Cipla to market the first inhaled insulin treatment option for adults living with diabetes in India and expect to prepare product for export by the end of 2025.”
Read the MannKind Corporation press release.
