New Delhi On 8 November, the US Food and Drug Administration (FDA) approved the use of tirzepatide by US pharma company Eli Lilly exclusively for obesity management.
The injectable tirzepatide is indicated for type 2 diabetes with the additional benefit of causing weight loss, and has been a global smash hit since its launch in 2022.
It goes under the brand name Mounjaro for diabetes, and Zepbound for weight loss.
The drug maker, it is learnt, has also sought regulatory approval in India for diabetes treatment, and the application is currently under review.
“For tirzepatide T2D (type 2 diabetes) indication, the application is currently under review with the Indian drug regulatory authorities,” a company spokesperson told ThePrint in response to a query.
The spokesperson added that Eli Lilly had filed for approval of all available dose strengths for tirzepatide T2DM (Type 2 diabetes mellitus) indication in India.
ThePrint reached Drugs Controller General of India Rajeev Singh Raghuwanshi by call for a comment, but hadn’t received a response by the time of publishing.
The USFDA approval for Zepbound comes for adults with obesity (with a BMI of 30 kg/square metre or greater), or those who are overweight (with a BMI of 27 kg/square metre or greater) and also have weight-related medical problems such as hypertension, dyslipidemia (high cholesterol), type 2 diabetes mellitus, obstructive sleep apnoea or cardiovascular disease, to lose weight and keep it off.
Lilly said in a statement that the USFDA approval was based on results from the phase 3 trials, which involved 2,539 adults with obesity, or excess weight and weight-related medical problems not including diabetes, adding that use of the drug may be associated with gastrointestinal side-effects.
According to the researchers behind the study, people taking Zepbound as an adjunct to their diet and exercise experienced substantial weight loss at 72 weeks, compared with the placebo.
At the highest dose (15 mg), people taking Zepbound lost an average of 21.7 kg, while at the lowest dose (5 mg), the loss averaged 15.4 kg.
Additionally, 1 in 3 patients taking Zepbound at the highest dose lost over 25 percent of their body weight, compared to 1.5 percent on the placebo, the study found.
The average starting weight of participants was 104.7 kg.
Participants on average lost about 22.5 percent of their body weight after 72 weeks of using the drug, the study found.
The company said study participants who dieted, exercised and took Zepbound also observed changes in cholesterol and reductions in blood pressure, but clarified that the drug is not approved to treat these conditions.
According to the company, Zepbound is expected to be available in the US by the end of the year in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) at a list price of $1,059.87 (Rs 88,252), which is approximately 20 percent lower than a semaglutide 2.4-mg injection for weight loss.
A low strength of semaglutide, which is available in the US under the brand names Wegovy (for obesity) and Ozempic (for diabetes), is also available in India in the pill form, under the brand name Rybelsus.
Also Read: Desperate Indians want Ozempic on prescription. Huge shift from traditional drugs, say doctors
Tirzepatide vs semaglutide
Drugs like semaglutide and tirzepatide work by binding to the receptors of various gut hormones.
These receptors regulate the secretion of pancreatic hormones as well as gut function, and their malfunctioning aggravates type 2 diabetes and obesity.
Eli Lilly has said that Zepbound is the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.
The drug, like semaglutide, has the effect of creating a feeling of fullness for longer, thus reducing appetite.
“Weight loss is believed to occur at the central level (hypothalamus) where they reduce the appetite and promote early satiety,” gastroenterologist Dr Rajeev Jayadevan had earlier told ThePrint.
The medicine, however, is not without side effects. The company clarified that Zepbound use may be associated with adverse gastrointestinal reactions, sometimes severe.
The most commonly reported adverse events — observed in nearly 5 percent of clinical trial participants — were nausea, diarrhoea, vomiting, constipation, abdominal pain, fatigue, hypersensitivity reactions, hair loss and gastroesophageal reflux disease, it said.
In the study, said the statement, most nausea, diarrhoea and vomiting occurred when people increased their dose — but the effects generally decreased over time.
“In studies, gastrointestinal side-effects were more common in people taking Zepbound than people taking placebo, and people taking Zepbound were more likely than those on placebo to stop treatment because of these side-effects,” it said.
Then there is another caveat.
“When the injections are stopped, patients tend to gain the weight back, especially if their food intake returns to previous levels,” Jayadevan said.
(Edited by Sunanda Ranjan)