Cipla Secures CDSCO Approval for Marketing Inhaled Insulin in India
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Mumbai, Dec 11 (NationPress) The Central Drugs Standard Control Organisation (CDSCO) of India has granted Cipla the exclusive rights to distribute and market inhaled insulin within the country, as stated by the pharmaceutical company on Wednesday.
The inhaled insulin, known as Afrezza, is developed and produced by MannKind Corporation and is intended to enhance glycemic control in adults diagnosed with diabetes mellitus.
According to the company, “Afrezza is a rapid-acting insulin that is administered via an inhaler, contrasting with traditional insulins that are injected. When taken at the start of a meal, Afrezza quickly dissolves upon being inhaled into the lungs, providing insulin to the bloodstream in a timely manner.”
Cipla's goal is to ensure that this medication is accessible to all, enabling millions to manage their health more effectively.
The company pointed out that Afrezza begins to take effect in as little as 12 minutes and is designed to mitigate the sharp rise in blood sugar levels following meals.
The duration of Afrezza's effect is approximately 2-3 hours, closely mimicking the body’s natural insulin response. This product marks the first and only non-injectable insulin formulated for individuals with both type 1 and type 2 diabetes mellitus, according to the company.
“By minimizing the requirement for multiple daily insulin injections, we are providing a convenient alternative for individuals managing diabetes mellitus, especially those who experience discomfort with needles, thus facilitating better disease management,” remarked Umang Vohra, Managing Director and Global CEO of Cipla.
Afrezza has undergone assessment in over 70 clinical trials involving more than 3,000 patients in total. A phase 3 clinical trial conducted in India with 216 participants demonstrated a notable decrease in HbA1c levels when Afrezza was added to existing oral anti-diabetes treatments.
The introduction of inhalable insulin represents a pioneering option for individuals facing diabetes mellitus, as stated by the company.
Afrezza has been approved in the United States for over 10 years and has been prescribed to tens of thousands of patients. MannKind will supply Afrezza to Cipla, which will subsequently oversee sales and marketing efforts in India.
