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In a significant development for diabetes management in India, the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Cipla to exclusively distribute and market inhaled insulin in the country. The drug, known as Afrezza, is created and manufactured by MannKind Corporation and is designed to improve glycemic control in adults with diabetes mellitus.
Afrezza is a rapid-acting insulin delivered through an inhaler, a notable departure from traditional insulin injections. “Taken at the beginning of a meal, Afrezza dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream,” Cipla stated. This new method aims to make diabetes management more accessible and less cumbersome for patients.
Cipla emphasized that Afrezza begins to work in as little as 12 minutes and helps reduce the rapid increase in blood sugar levels typically seen after meals. The effect of Afrezza lasts for about 2-3 hours, closely mimicking the body’s natural insulin response. This makes Afrezza the first and only non-injectable insulin available for patients with both type 1 and type 2 diabetes mellitus.
“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,” said Umang Vohra, Managing Director and Global CEO of Cipla.
Afrezza has been evaluated in over 70 clinical studies involving more than 3,000 patients globally. A phase 3 clinical trial conducted on 216 patients in India showed a significant reduction in HbA1c levels when Afrezza was added to oral anti-diabetes medications.
Cipla highlighted that the availability of inhaled insulin represents a new and innovative option for diabetes patients, potentially transforming their treatment regimen. Afrezza has been approved in the United States for more than a decade and has been prescribed to tens of thousands of patients. MannKind Corporation will supply Afrezza to Cipla, who will handle the sales and marketing activities in India.
This approval marks a promising advancement in the field of diabetes care, providing a more convenient and patient-friendly alternative to traditional insulin therapy.
