An innovative inhaled insulin option is on its way for people living with diabetes as Cipla, a prominent pharmaceutical company, prepares to import Afrezza from MannKind Corporation in the United States.
Afrezza is a rapid-acting insulin that is inhaled rather than injected, marking a significant advancement in diabetes management. Having gained regulatory approval in the U.S. nearly a decade ago, it has recently received clearance from India’s Central Drugs Standard Control Organisation, allowing Cipla to exclusively distribute and market the inhalation powder in India.
This product is unique, offering convenience for individuals who require multiple insulin injections and have apprehensions about needles. However, healthcare professionals advise caution for patients with conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other serious respiratory issues, as Afrezza is not recommended for them.
Dr. Saptarshi Bhattacharya, a senior consultant at Indraprastha Apollo Hospitals in New Delhi, highlighted that Afrezza is used as a short-acting insulin taken before meals to help manage post-meal blood sugar spikes. It serves as an additional option for those already following a regimen with both long-acting and short-acting insulins. He echoed the importance of avoiding this inhaled insulin for patients who suffer from asthma or other severe lung ailments.
Agreeing with Dr. Bhattacharya, Dr. Abhijit Bhograj, an endocrinologist at Manipal Hospital in Hebbal, mentioned that inhaled insulin provides added convenience for individuals who need to manage their diabetes with multiple injections. While Cipla has not yet disclosed detailed information regarding the product or its pricing, he noted that the device is designed to deliver a precise metered dose of insulin. Afrezza can be used by both Type 1 and Type 2 diabetes patients, though it remains contraindicated for those with respiratory diseases.
In the past, inhaled insulins were introduced by companies like Pfizer (Exubera) and Sanofi (Afrezza), but both were eventually discontinued. Industry insiders suggest that these decisions were more about strategic shifts within those companies rather than concerns about the safety or effectiveness of the product. Diabetologists have emphasized the necessity for ongoing long-term studies to evaluate the inhaled insulin’s efficacy.
Dr. Jaideep Gogtay, Cipla’s Global Chief Medical Officer, explained why the company believes that Afrezza might succeed where its predecessors did not. Cipla has a strong background in inhalation therapy, and the pharmacokinetics of Afrezza, which align closely with the body’s natural insulin response, contributed to the decision to pursue this product.
When inhaled at the beginning of a meal, Afrezza rapidly dissolves in the lungs and swiftly enters the bloodstream, with effects observable in as little as 12 minutes. This ability to mitigate post-meal spikes in blood sugar levels is a significant benefit. Dr. Gogtay expressed optimism that the product could be available by the end of the current financial year (March 2025), although pricing details are still being finalized. A recent phase 3 clinical trial conducted with 216 participants in India demonstrated notable reductions in HbA1c levels when Afrezza was added to oral anti-diabetes medications, according to Cipla.
