New Delhi: Eli Lilly India, makers of the obesity drug Mounjaro, said Thursday that they have received approvals from the Indian regulator for their pre-filled pen, a day after competitor Novo Nordisk’s global mega-selling drug for obesity, Wegovy, hit the Indian markets. The pens offer a convenient way for patients to take their medication.
Mounjaro by US-based Eli Lilly & Company, which has tirzepatide as its active pharmaceutical ingredient (API), was launched in India on 20 March this year in vial format, which meant it was more cumbersome to administer.
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Mounjaro in the KwikPen presentation, Eli Lilly said in a statement Thursday, adding that the approval marks an important step in advancing care for people living with type 2 diabetes and obesity in India.
First developed as a treatment for type 2 diabetes in lower doses, both Mounjaro and Wegovy are weekly injections intended to dramatically reduce weight in obese patients. They have emerged as global sensations in the pharmaceutical market world over, with their sales reaching multi-billion-dollar figures.
These drugs have also been fighting to dominate the obesity management space in many developed countries. They are now aiming to capture a share of the market in India, where obesity is growing rapidly, driven by changing dietary and lifestyle patterns. India’s anti-obesity drug market is currently valued at Rs 3,000-3,500 crore, and is projected to grow nearly eightfold to Rs 25,000 crore by 2030, according to market estimates.
A 2023 survey by the Indian Council of Medical Research (ICMR) and Madras Diabetes Research Foundation (MDRF) had shown that 25.4 crore Indians, or 28.6 percent, of the population had generalised obesity.
Obesity, now recognised as a chronic, relapsing disease, is a major risk factor for diabetes and is linked to over 200 health complications, including hypertension, dyslipidemia or high blood cholesterol, coronary heart disease, and obstructive sleep apnea.
Also Read: Fat-busting drug Mounjaro launched in India. Here’s how much it will cost
Promise of simplified treatment
KwikPen, or Mounjaro, is a multi-dose, prescription-based, single-patient-use pre-filled pen designed for once-weekly administration, the company said. It also added that the full range of doses for Mounjaro—2.5 mg to 15 mg—will be available in India soon, supporting personalised treatment as recommended by treating physicians. Earlier, the vial format of the drug was launched in only two dosage strengths—2.5 mg and 5 mg—in the country.
The latest announcement came after Wegovy, which has semaglutide as its API, got a strategic launch in India as an innovative, easy-to-use pre-filled pen called FlexTouch devices. It was aimed at stealing the thunder Mounjaro had by reaching Indian patients first. A less potent version of semaglutide, in the form of an oral pill-under the brand name of Rybelsus, has been available in India since 2022 for the treatment of diabetes.
The Wegovy pre-filled pen has been launched in five dosing strengths: 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg. While the monthly cost of the first three dosages is Rs 17,345, the higher doses will cost Rs 24,280 and Rs 26,050, respectively. Mounjaro, in the vial format, was launched at a cost of Rs 14,000 (for 2.5 mg) and Rs 17,500.
Eli Lilly, however, has yet to decide the price of the Mounjaro KwikPen for all five dosages.
Meanwhile, experts ThePrint spoke to said pre-filled pens will simplify treatment, making these powerful anti-obesity and diabetes medications more convenient for patients.
“With simplified administration, adherence improves, helping more individuals achieve better weight and metabolic health outcomes,” explained Mumbai-based diabetologist Dr Rajiv Kovil. Senior diabetologist and researcher Dr V. Mohan also said this could make a profound impact on the lives of lakhs of people in India.
Mounjaro vs Wegovy—which is more effective
Both tirzepatide and semaglutide, the prescription-only drugs, mimic the effects of natural gut hormones that work by lowering caloric intake, primarily by influencing appetite control mechanisms.
Tirzepatide is a dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, while semaglutide functions as a mono GLP-1 receptor agonist. Both GIP and GLP-1 are natural incretin hormones, that stimulate a decrease in blood glucose levels, found in brain regions that regulate appetite.
In May this year, Lilly said in a statement that a head-to-head clinical trial comparing tirzepatide and semaglutide in their maximum tolerable doses showed the former to be significantly more effective than the latter in reducing both weight and waist circumference after 72 weeks of treatment. According to the US-based pharma giant, participants administered tirzepatide saw an average weight reduction of 20.2 percent, while those on semaglutide experienced a 13.7 percent loss—indicating a 47 percent greater relative weight loss for the former, based on the treatment regimen estimated at 72 weeks.
But one advantage that semaglutide has in the higher dose strength is its ability to also treat several other metabolic conditions, such as cardiovascular diseases and kidney disorders. While Mounjaro is better than Wegovy in percentage of weight loss, there is stronger evidence in the case of Wegovy for reducing cardiovascular conditions in obese people without diabetes and also for treating kidney and diabetes, experts said.
During the launch of Wegovy on 24 June, Novo Nordisk underlined that the drug is the only medication approved in India for treating major adverse cardiovascular events (MACE), along with obesity.
Diabetologist Kovil said, “If there is an obese patient who does not have other major underlying issues yet, I will be more inclined towards prescribing Mounjaro.”
He added that, in patients with comorbidities such as diabetes, liver or kidney disorder or cardiovascular condition, Wegovy could be a better choice as it reduces mortality and improves longevity.
In response to queries by ThePrint, Eli Lilly said that Mounjaro offers a novel approach to metabolic health management, giving treating physicians an innovative option for treating both diabetes and obesity.
“Ultimately, it is up to physicians to determine the most appropriate treatment based on individual patient needs and clinical judgment,” said the drugmaker.
According to Dr Ambrish Mithal, chairman and head, endocrinology and diabetes with Max Healthcare, anti-obesity drugs can be indicated for people with a BMI (Body Mass Index) of 30 and above in the absence of other comorbidities. However, in people with other pre-existing conditions, either of the drugs can be initiated at a BMI of 27 and above, in conjunction with diet, lifestyle changes and under expert supervision, he said.
Experts also warn about the possible side effects of GLP-1 agonist drugs amid concerns around misuse of these drugs in India, given the regulatory loopholes which allow patients to access most prescription drugs over the counter.
Large clinical trials and post-marketing evidence following use of these medicines have shown that while nausea, bloating, vomiting and diarrhoea are comparatively mild side effects of these medications. In rare cases, they can also cause stomach paralysis, a disorder that affects the normal movement of the stomach muscles.
In a response to queries by ThePrint, Eli Lilly emphasised that Mounjaro is a prescription-only drug and should be taken strictly under a doctor’s supervision.
“Tirzepatide is not approved for, and should not be used for, cosmetic weight loss or by individuals under 18. Lilly neither promotes nor encourages the unapproved use of tirzepatide by anyone,” the company said.
(Edited by Sanya Mathur)
Also Read: Mounjaro will shrink India’s appetite for packaged food, gyms, weight loss supplements