Drugmaker Cipla has got regulatory approval to market Afrezza, a rapid acting insulin delivered through an inhaler, as compared to other insulins given through injections.

The Central Drugs Standard Control Organisation (CDSCO) has given Cipla the approval to exclusively distribute and market Afrezza (human insulin) inhalation powder in India, the company said. 

Developed and manufactured by MannKind Corporation (US), Afrezza helps improve Glycemic control in adult patients with diabetes mellitus, Cipla said.

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“The effect of Afrezza lasts for about 2 to 3 hours and it closely resembles the body’s own response to insulin. This is the first and only non- injectable insulin to be developed for patients of both type 1 and type 2 diabetes mellitus,” the company added.  

“Taken at the beginning of a meal, Afrezza dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream”, a note from Cipla said.

The product starts working in as early as 12 minutes and helps in reducing the rapid increase seen in sugar levels with meals, it added.

MannKind will supply Afrezza to Cipla, who will then market it in India, the company said. Details of price and the timeline when it would be available to patients was not readily available from the company.

“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,” said Umang Vohra, Cipla Managing Director and Global Chief Executive Officer.

“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,” he added.

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India trials

Jaideep Gogtay, Cipla’s Global Chief Medical Officer, 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 anti- diabetes medications.

“The availability of insulin to be inhaled through the lungs will provide a new and innovative option for patients with diabetes mellitus,” he added.

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Afrezza has been evaluated in over 70 clinical studies involving more than 3,000 patients overall. It has been approved in the US for more than 10 years and has been prescribed for tens of thousands of patients, Cipla said.

Achin Gupta, Cipla’s CEO, One India Business, added, the innovative product would delivered across the country, through its extensive distribution network.