Eli Lilly and Company has approached the Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO), for seeking approval of its blockbuster drug tirzepatide which is used to treat type 2 diabetes. Launched under the brand name Mounjaro in the US last year, it is also being used as a weight-loss drug, and though it hasn’t been officially approved for this use, it has shown promising results in clinical trials. In an interaction with Moneycontrol, Vineet Gupta, managing director of Elli Lilly and Company, India, said the firm has approached the CDSCO for the drug’s approval in the country.
“Tirzepatide is our next innovation in diabetes management,” he said. “We are making best efforts to secure regulatory approvals so that patients in India can benefit from this innovation at the earliest.” Here is an explainer on Mounjaro and why it has hit the headlines worldwide.
What is Mounjaro?
Similar to Ozempic and Wegovy (two different versions of diabetes drug semaglutide by Novo Nordisk), Mounjaro is a glucagon-like peptide-1 (GLP-1) receptor agonist (a type of drug used to treat diabetes and aid weight loss) and is also a glucose-dependent insulinotropic polypeptide (GIP), a hormone that helps with the release of insulin after food consumption, pointed out Dr Anupam Biswas, consultant endocrinologist with Fortis Hospital in Noida.
“It is a single molecule that targets the body’s receptor for both GIP and GLP-1 which are both natural incretins (hormones that are released from the gut into the bloodstream in response to ingestion of blood),” explained Dr Biswas.
The US Food and Drug Administration had approved the drug as a once-weekly injection in adults with type 2 diabetes to reduce blood sugar and it is suggested for use with diet and exercise. The medicine has also been found in clinical trials to be useful for weight loss but currently is not approved for losing weight.
What may be its advantage over weight loss drug Ozempic?
The availability of Mounjaro has got both doctors and patients excited in the US and reports said that the drug is helping Eli Lilly turn into the most valuable standalone pharmaceutical company in the country with a market value of over $ 300 billion.
But what sets it apart from other weight-loss drugs and specifically another blockbuster drug, Ozempic?
Dr Biswas pointed out that results from Surpass trial (a multi-country clinical trial to check the efficacy of tirzepatide) have shown that the drug leads to significant reduction in HbA1c (a marker of diabetes) and body weight and is a boon for diabetic patients.
Another trial comparing the drug with semaglutide showed that Mounjaro helped people who have difficulty losing kilos despite dieting cut their weight by up to 22.5 percent over 72 weeks during testing.
In comparison, the two versions of semaglutide, Ozempic, and Wegovy, which share the same active ingredient, induced weight loss of up to around 18 percent in the trials.
Is the drug going to be available in India in the near future?
According to Gupta, the company has already applied for the drug’s approval in the country but refused to reply on whether the medicine would be available here in injectable form or as an oral pill.