CDSCO approves Cipla to distribute, market inhaled insulin in India

Mumbai, Dec 11 Indian regulator Central Drugs Standard Control Organisation (CDSCO) has approved Cipla to exclusively distribute and market inhaled insulin in the country, the drugmaker said on Wednesday.

The insulin called Afrezza is created and manufactured by MannKind Corporation, and is used to improve glycemic control in adults 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,” the company said.

Cipla aims to make the drug accessible to all and empower millions to take control of their health with greater ease.

The company noted that Afrezza will start working in as early as 12 minutes and help 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 first and only non-injectable insulin to be developed for patients of both type 1 and type 2 diabetes mellitus, the company said.

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Afrezza has been evaluated in over 70 clinical studies involving more than 3,000 patients overall. A phase 3 clinical trial conducted on 216 patients in India showed a significant reduction in HbA1c levels when patients added Afrezza 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, the company said.

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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