Cipla gets approval for distribution and marketing of inhaler insulin in India

Mumbai, December 12 (IANS). Drug maker Cipla on Wednesday said Indian regulator Central Drugs Standard Control Organization (CDSCO) has given it approval to exclusively distribute and market inhaled insulin in the country.

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 via an inhaler,” the company said. Currently insulin is given in the form of injection. Afrezza, taken at the beginning of a meal, dissolves rapidly in the lungs and delivers insulin rapidly into the blood.

Cipla aims to make medicine accessible to all and enable millions of people to more easily control their health.

The company said Afrezza will start working in 12 minutes and will help reduce the sharp rise seen in sugar levels with meals.

The effect of Afrezza lasts for about two-three hours and it has a very similar effect to that of insulin. The company said it is the first and only non-injectable insulin developed for patients with both type 1 and type 2 diabetes mellitus.

Cipla Managing Director and Global CEO Umang Vohra said, “By reducing the need to inject insulin multiple times per day, we are providing a convenient solution for people suffering from diabetes, especially those who have to deal with the need for injections. This will help them handle their situation more effectively.”

Afrezza has been evaluated in more than 70 clinical studies involving more than three thousand patients. Its use showed a significant reduction in HbA1c levels in a clinical trial conducted on 216 patients in India.

The company said the availability of insulin to be inhaled through the lungs will provide a new option for diabetic patients.

Afrezza has been available in the US for more than 10 years. This medicine is being given to thousands of patients. Now, Mankind will supply Afrezza to Cipla and Cipla will sell it in India.

–IANS

MKS/AKJ

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