An “inhaled insulin” is set to join the repertoire of options available to people with diabetes, as drugmaker Cipla completes last mile procedures to import Afrezza from US’ MannKind Corporation.

A rapid acting insulin, Afrezza is delivered through an inhaler, unlike others given through injections. And the product had received US regulatory approvals about 10 years ago. Recently, India’s Central Drugs Standard Control Organisation gave Cipla the approval to exclusively distribute and market Afrezza (human insulin) inhalation powder in India, the company said.

A first of its kind, diabetologists point out, the inhaled product would be convenient, for those taking multiple insulin shots and wary of injections. But they also sounded a note of caution for those with asthma, COPD (chronic obstructive pulmonary disease) and other serious lung-related concerns, for whom it is not advised.

Dr Saptarshi Bhattacharya, Senior Consultant, Indraprastha Apollo Hospitals, New Delhi explained that Afrezza is a short-acting insulin, taken ahead of a meal to control the sugar-spike usually seen after a meal. It is an add on product for those with diabetes, who may already be on a mixed regimen of long-acting and short acting insulins, he said. Dr Bhattacharya cautioned, the inhaled insulin is not advised for those with asthma and other serious lung-ailments.

Dr Abhijit Bhograj, endocrinologist, Manipal Hospital, Hebbal agreed that inhaled insulin “adds a layer of convenience” to those taking multiple insulin injections a day. While details of the product and pricing are still to be revealed by Cipla, Dr Bhograj says, the device would deliver a metered dose of the formulation.  The product could be used by people with Type 1 and Type 2 forms of diabetes, he said, adding that it was not advised for those with asthma, COPD etc.

Inhaled insulins had emerged on the global landscape twice in the past — from Pfizer (Exubera) and Sanofi ( Afrezza) – only to be discontinued, or returned (to MannKind), respectively .  Industry insiders explain, that decision had more to do with shifting priorities and sales for the companies, rather than safety and efficacy of the product. Diabetologists, though, stressed the need for continued long term studies on the product.  

India trials

Explaining why Cipla thinks an inhaled insulin product would be third time lucky, in a sense, and what clinched the decision to go with Afrezza – Dr Jaideep Gogtay, Cipla’s Global Chief Medical Officer told businessline, that inhalation therapy was a segment that Cipla understood well. And, the profile of Afrezza – in that it resembled the body’s response, as compared to other insulins – also helped the decision.

“Taken at the beginning of a meal, Afrezza dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream”, a Cipla note explained. The product starts working in as early as 12 minutes and helps in reducing the rapid increase seen in sugar levels with meals, it added.

Gogtay was hopeful the product would be available by the end of this financial year (March 2025).  Pricing of the product was still being finalised, he added. A  phase 3 clinical trial conducted in 216 patients in India showed a significant reduction in HbA1c levels with Afrezza when added to oral anti- diabetes medications, Cipla said.