MannKind Corporation and Cipla Ltd. announced that the Central Drugs Standard Control Organisation (CDSCO) in India has approved Afrezza (insulin human) Inhalation Powder in adults. The CDSCO decision follows existing approvals in the United States and Brazil.
“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,” said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation. “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.”
MannKind entered into an exclusive marketing and distribution agreement for Afrezza in India with Cipla Ltd., a global pharmaceutical company, in May 2018. Under the terms of the agreement, Cipla was responsible for obtaining regulatory approvals to distribute Afrezza in India as well as marketing and sales activities. MannKind is responsible for supplying Afrezza to Cipla.
“The availability of Afrezza has the potential to help so many people in India living with diabetes in improving glycemic control via a non-injectable and convenient delivery of inhaled insulin,” said Dr. Satish Garg, MBBS, DM, Professor of Medicine and Pediatrics at the Adult Clinic of the Barbara Davis Center for Diabetes of the University of Colorado School of Medicine in Denver.
The International Diabetes Federation (IDF) reported in 2021 that diabetes mellitus affects 537 million adults (20-79 years of age) worldwide, including more than 74 million people in India. IDF estimations are that the total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.
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