MannKind Corporation and Cipla Ltd. Celebrate Approval of Inhaled Insulin Afrezza by CDSCO in India
MannKind Corporation, renowned for developing cutting-edge inhaled therapeutic products and devices tailored for patients with endocrine and rare lung ailments, alongside Cipla Ltd., have announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved Afrezza, an inhalable insulin for adults. This decision by the CDSCO mirrors previous endorsements received in the United States and Brazil.
“Securing approval for Afrezza in India — a nation grappling with the second-largest diabetes epidemic globally — marks a significant achievement for MannKind and our strategic ally, Cipla,” expressed Michael Castagna, PharmD, MannKind Corporation’s CEO. “We’re eager for Cipla to introduce the first inhaled insulin option for Indian adults with diabetes and anticipate preparing product exports by late 2025.”
Since May 2018, MannKind has maintained an exclusive marketing and distribution partnership with the global pharmaceuticals giant, Cipla Ltd., specifically for Afrezza’s Indian market. The agreement situates Cipla as responsible for obtaining necessary regulatory clearances and spearheading marketing and sales initiatives within India, while MannKind is tasked with product supply to Cipla.
“Afrezza’s availability presents a promising opportunity for many diabetes patients in India to enhance glycemic management without injections, offering a more convenient, inhaled insulin delivery,” noted Dr. Satish Garg, MBBS, DM, a distinguished Professor at the University of Colorado School of Medicine’s Barbara Davis Center for Diabetes Adult Clinic.
The International Diabetes Federation (IDF) reported in 2021 that diabetes impacts 537 million adults (ages 20-79) worldwide, including over 74 million individuals in India. IDF also predicts that by 2030, this number could escalate to 643 million globally, further surging to 783 million by 2045.
Afrezza is a rapid-acting inhaled human insulin, specifically prescribed to manage blood sugar levels in adult patients with diabetes.
Limitations of Use: Afrezza is not advised for diabetic ketoacidosis treatment and is unsuitable for patients who smoke or have recently quit smoking.
MannKind Corporation remains committed to innovating and commercializing advanced inhaled therapeutic solutions to fulfill significant unmet medical requirements for individuals battling endocrine and rare lung diseases.