Lilly eyes weight reduction enviornment for diabetes drug Tirzepatide after constructive information
Shortly after a re-minted label for type II diabetes (T2D), Eli Lilly is now paving the way for Tirzepatide to expand its reach as a weight-loss drug. The company’s presentation at the 82nd Scientific Sessions of the American Diabetes Association (ADA) not only put Tirzepatide in the spotlight for T2D, but also highlighted its potential in obesity.
Following an approval in May, the company announced that the GIP/GLP-1 dual receptor agonist tirzepatide, marketed as Mounjaro for T2D, will soon be available in US pharmacies. Mounjaro received FDA approval on May 13 to improve glycemic control in people with T2D. Eligible T2D patients with commercial insurance must spend $25 per month to receive Mounjaro with a copay program, according to the company’s ADA presentation.
According to GlobalData, sales of Tirzepatide are expected to reach US$6.8 billion in 2028. GlobalData is the parent company of Pharmaceutical Technology.
At the ADA, Lilly presented data from 2,539 participants in the phase III SURMOUNT-1 study in which tirzepatide demonstrated “statistically superior and clinically meaningful weight reduction” at three different doses compared to the control arm.
A Lilly spokesman told Pharmaceutical Technology the company could not comment on the future availability of the drug as an anti-obesity drug. But: “Lilly recognizes the need for potential new treatments for this chronic disease. As with any potential treatment, our goal is to make our medicines available and accessible to as many people as possible.”
While tirzepatide showed efficacy in the SURMOUNT-1 trial as a once-weekly weight-loss treatment in overweight and obese patients, the question remains how the drug will be reimbursed if approved in this indication.
Reimbursement reservations and approval plans
Insurance reimbursement for anti-obesity drugs remains a barrier to patients seeking such drugs in the United States. Weight control medications are not a mandatory Medicaid benefit, and Medicare excludes coverage for all obesity medications.
Even if a drug has been studied in other metabolic diseases, the FDA requires data from a cardiovascular outcomes study (CVOT) for regulatory approval as a treatment for obesity.
Lilly expects a data read-out for its T2D SURPASS-CVOT study in 2024 and is conducting a SUMMIT study evaluating tirzepatide in heart failure patients with preserved ejection fraction (HFpEF) and obesity with an expected end date in November 2023.
The Lilly spokesperson said the company initially coordinated with the FDA to support the results of all four global SURMOUNT studies to: a [regulatory] Submission to chronic weight control. However, the data from the SURMOUNT-1 study appears to have been significant enough for the company to accelerate its strategy.
“We look forward to reviewing the tirzepatide data with the FDA and discussing a potentially accelerated path forward, and we should have an updated timeline by the end of the year,” the spokesman said.
The company’s presentation indicated that tirzepatide improved the pre-specified cardiometabolic secondary endpoints in SURMOUNT-1 and additional SURMOUNT-2, 3, 4 studies are ongoing with data expected to be available over the next year.
The competitors in the weight loss market
The FDA has approved six drugs for long-term use in the treatment of obesity and overweight. A body mass index (BMI) between 25 and 30 is defined as overweight, and over 30 is considered obese. Novo Nordisk’s Semaglutide, marketed as Wegovy when used to treat obesity and injectable Ozempic and oral Rybelsus for T2D, is one of the recent entrants in this space.
Other options include Orlistat sold by H-2 Pharma under the name Xenical and OTC Alli by GSK, Qsymia (phentermine topiramate) by Vivus, Contrave (naltrexone bupropion) by Currax Pharmaceuticals. Novo Nordisk’s liraglutide is sold under the brand names Saxenda for obesity and Victoza for T2D, while Rhythm Pharmaceutical’s Imcivree (setmelanotide) is restricted to people with rare genetic disorders.
Highest dose with highest effectiveness
In SURMOUNT-1, the greatest weight reduction was seen in the 15 mg arm, with participants losing 24 kg (52 lb) at 72 weeks. The average age of the participants was 45, and about two-thirds of them were women, says Dr. Nadia Ahmad, Senior Medical Director of the Tirzepatide Obesity Program. Baseline BMI was 38, with all participants being overweight or obese, having high blood pressure, obstructive sleep apnea, or cardiovascular disease.
Ahmad adds that 41% of the participants had prediabetes, a condition in which blood sugar levels are higher than normal but do not reach the baseline level of the T2D diagnosis. These participants will continue treatment for the next two years in an extension study, according to ClinicalTrials.gov, but by the end of the 72-week study, more than 95% of these individuals had returned to normal blood sugar levels, Ahmad notes.