• India's CDSCO has approved Cipla to distribute and market inhaled insulin, Afrezza, developed by MannKind Corporation.
• Afrezza, a rapid-acting insulin, dissolves swiftly upon inhalation and enters the bloodstream, offering an alternative to injectable insulins.
• The drug begins working within 12 minutes and lasts for about 2-3 hours, mimicking the body's natural insulin response.
• Afrezza's approval marks a significant milestone in diabetes treatment in India, providing a new, convenient treatment option for patients.

In a significant stride for diabetes treatment in India, the Central Drugs Standard Control Organisation (CDSCO) has given the nod to pharmaceutical giant Cipla to exclusively distribute and market inhaled insulin, Afrezza, in the country. This groundbreaking product, developed and manufactured by MannKind Corporation, is designed to enhance glycemic control in adults diagnosed with diabetes mellitus.

Afrezza is a rapid-acting insulin delivered through an inhaler, providing an alternative to traditional injectable insulins. Upon oral inhalation at the onset of a meal, the insulin dissolves swiftly and is delivered rapidly into the bloodstream. This innovative approach aims to make the drug accessible to all, empowering millions of individuals to manage their health with greater ease and comfort.

The company stated that 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. This innovation is the first and only non-injectable insulin available for patients with both type 1 and type 2 diabetes mellitus.

A Convenient Solution for Diabetes Management

Umang Vohra, Managing Director and Global CEO of Cipla, highlighted the potential benefits of this new treatment option, stating, "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."

Afrezza has undergone extensive evaluation 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 drug 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 then be responsible for sales and marketing activities in India.

Global Advancements and Challenges in Diabetes Treatment

This development comes at a time when the global diabetes treatment landscape is witnessing significant advancements. For instance, UNC Children's Hospital is now offering infusions of Tzield, a therapy that can prevent or delay the onset of Type 1 diabetes. Eli Lilly's once-weekly insulin injection has also shown promising results in managing A1C levels in diabetes.

However, the journey towards improved diabetes treatment is not without challenges. Supply issues have been reported in the U.K. and South Africa, leading to concerns about insulin manufacturers' interest in production. Meanwhile, researchers are exploring new avenues, such as the regeneration of insulin-producing cells in the pancreas and the development of nano-scale materials that can react to the body's blood sugar levels.