Updated: Eli Lilly’s tirzepatide breaks into obesity market with FDA approval

Eli Lilly’s tirzepatide is officially entering the market for chronic weight management.

The drugmaker said Wednesday that the GIP/GLP-1 receptor agonist, which is known as Mounjaro for type 2 diabetes, can now be marketed as Zepbound for weight management in adults with obesity or overweight with “weight-related” health conditions.

It is set to be available in the US by the end of the year, in six doses with a list price of $1,059.87. According to Lilly, that price is about 20% lower than the list price of a 2.4 mg dose of Wegovy, Novo Nordisk’s GLP-1 for weight loss. The list price for Wegovy is $1,349.02 per package, according to Novo’s website.

Dave Ricks

During a media call on Wednesday, Lilly CEO Dave Ricks said that patients who have commercial insurance could pay as low as $25 a month, and the price for those who do not have commercial insurance may be as low as 50% off.

Another executive — Mike Mason, the president of Lilly Diabetes and Obesity — said the pricing decision was made to improve access to anti-obesity medications.

“As we were talking to the end payers like the employers, they said that the list price was something that was a factor in their decision to expand access to people who need these medications,” he said during the call.

Mike Mason

“Usually when you bring out innovations like this within the pharmaceutical industry, you’ll take a nominal price premium to competitor drugs, and in this case, we decided to take a 20% discount to the main competitor semaglutide 2.4 and really in order to expand the class,” Mason added. “Quite simply, that’s what we’re trying to do and that was the strategy and approach behind that.”

The therapy has dominated the hearts and minds of both researchers and the public alike as interest in GLP-1s has soared in recent years. Though it hasn’t been approved for weight management until now, the drug’s been used off-label for patients trying to lose weight, leading to shortages and record-breaking revenue predictions for both Lilly and Novo Nordisk.

“Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it,” Mason said in a statement.

Lilly’s Phase III SURMOUNT-2 study showed that using the once-weekly treatment in patients with type 2 diabetes and obesity led to an average loss of 15.7% from their starting body weight after 72 weeks of treatment, compared with 3.3% weight loss on placebo. Those data were released in June at the American Diabetes Association’s annual conference.

Then in July, the drugmaker released more data from its SURMOUNT-3 and SURMOUNT-4 trials that showed patients lost up to 26% of their body weight, on average, across both trials.

For years, there have been few treatment options for patients with obesity, and physicians say that tirzepatide’s approval in weight management helps address a critical need to have as many tools as possible to treat a disease that affects 40% of adults in the US.

“We’re also now seeing more and more evidence — as far as other health benefits, as far as the magnitude of weight reduction that they’re achieving — … coming close now to some of the metabolic and bariatric surgical outcomes, which is exciting,” Kimberly Gudzune, the American Board of Obesity Medicine’s medical director and an associate professor at Johns Hopkins Medicine, told Endpoints News.

Gudzune, who’s been practicing obesity medicine for 13 years, noted that tirzepatide is different from other medications in the class because it affects both GLP-1 and GIP, another gut hormone.

“I’ve had some patients who cannot tolerate one of the GLP-1 agonists that are just single-focused, but do well on tirzepatide … They can tolerate it. They don’t have side effects,” she said. “That’s why having more tools available just gives us more options to better tailor care to that individual patient in front of us.”

In addition to Lilly’s SURMOUNT program, the Big Pharma is also planning a Phase III study investigating a subcutaneous form of tirzepatide versus placebo in obese or overweight adolescents. The study will last for about 90 weeks, with plans to enroll an estimated 150 patients in the randomized, double-blind trial.

This content was originally published here.

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