Diabetes management: Cipla bags CDSCO regulatory nod for distribution, marketing of Afrezza (insulin human) Inhalation Powder in India
Mumbai: Cipla Limited has announced that it has obtained regulatory approval from Central Drugs Standard Control Organisation (CDSCO) for the exclusive distribution and marketing of Afrezza (insulin human) Inhalation Powder in India.
Afrezza, a product created and manufactured by MannKind Corporation USA, is used to improve glycemic control in adult patients with diabetes mellitus.
Afrezza is a rapid-acting insulin delivered through an inhaler as compared to current insulins which are given as injections. Taken at the beginning of a meal, Afrezza dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream. Afrezza starts working in as early as 12 minutes and helps in reducing the rapid increase seen in sugar levels with meals. The effect of Afrezza lasts for about 2-3 hours and it closely resembles the body’s own response to insulin. This is the noninjectable insulin to be developed for patients of both type 1 and type 2 diabetes mellitus.
Umang Vohra, Managing Director and Global CEO, Cipla Limited, said, “Having pioneered inhalation therapy in India, we are proud to extend our innovation portfolio to diabetes management by partnering with MannKind for distribution of Afrezza. Cipla at its core is committed to redefining patient experiences and this advancement reflects that vision. By reducing the need for multiple daily insulin injections, we are offering a convenient solution for people living with diabetes mellitus, particularly those who are uncomfortable with needles, helping them manage their condition more effectively.”
Achin Gupta, CEO – One India Business, Cipla Limited, said, “The launch of Afrezza reinforces our dedication towards making cutting-edge treatments available to patients. By harnessing our extensive distribution capabilities, we are committed to delivering this innovation to communities across India, fostering better health outcomes for all.”
Dr Jaideep Gogtay, Global Chief Medical Officer, Cipla Limited, said, “A phase 3 clinical trial conducted in 216 patients in India showed a significant reduction in HbA1c levels with Afrezza when added to oral antidiabetes medications. The availability of insulin to be inhaled through the lungs will provide a new and innovative option for patients with diabetes mellitus.”
Afrezza has been evaluated in over 70 clinical studies involving more than 3,000 patients overall. Afrezza has been approved in the US for more than 10 years and has been prescribed for tens of thousands of patients. MannKind will supply Afrezza to Cipla, who will be then responsible for sales and marketing activities in India.
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