CDSCO approves Cipla to market inhaled insulin 'Afrezza' in India
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Afrezza (insulin human) Inhalation Powder.
Mumbai: The Central Drugs Standard Control Organisation (CDSCO), India’s drug regulatory authority, has granted Cipla exclusive rights to distribute and market inhaled insulin in the country, the pharmaceutical company announced on Wednesday.
The insulin, named Afrezza, is manufactured by MannKind Corporation and is designed to improve glycemic control in adults with diabetes mellitus.
Cipla described Afrezza as a rapid-acting insulin that is administered through an inhaler, offering an alternative to traditional injectable insulins. Taken at the beginning of a meal, the insulin dissolves quickly upon oral inhalation and is delivered rapidly into the bloodstream.
The company stated that it aims to make Afrezza widely accessible and to empower millions of individuals to manage their health with greater ease and comfort.
According to Cipla, Afrezza begins working within 12 minutes, helping to control the rapid spikes in blood sugar levels typically seen after meals. Its effects last for about 2-3 hours, closely mimicking the body’s natural insulin response. The company emphasized that this innovation is the first and only non-injectable insulin available for patients with both type 1 and type 2 diabetes mellitus.
Umang Vohra, Managing Director and Global CEO of Cipla, said the introduction of Afrezza reduces the need for multiple daily insulin injections, providing a convenient solution for people living with diabetes, particularly those uncomfortable with needles. He added that the innovation helps patients manage their condition more effectively.
Cipla highlighted that Afrezza has been evaluated in over 70 clinical studies involving more than 3,000 patients worldwide. In India, a phase 3 clinical trial conducted with 216 patients demonstrated significant reductions in HbA1c levels when Afrezza was added to oral anti-diabetes medications.
The company also noted that the availability of inhalable insulin in India represents a groundbreaking development for diabetes treatment.
Afrezza has been approved for use in the United States for over a decade and has been prescribed to tens of thousands of patients. Under the agreement, MannKind Corporation will supply Afrezza to Cipla, which will oversee sales and marketing activities across India.
With IANS inputs