Eli Lilly says its incretin drug tirzepatide is on track for approval in obesity later this year, following release of Phase 3 results which solidify its weight-loss profile.
Lilly announced data from its SURMOUNT-2 study of tirzepatide in obese diabetics Thursday, with the study showing about 16% weight loss. That equates to more than 34 pounds over nearly 17 months, the company said.
Weight loss in this late-stage study was expected to fall below the 21% seen in the earlier SURMOUNT-1 study, which included similar subjects without diabetes. Following the trial, Lilly said it will complete an application to the Food and Drug Administration for fast-track approval of tirzepatide in obesity over the coming weeks. Regulatory approval is expected by year’s end.
“We believe addressing obesity could make an enormous difference in millions of people’s lives, significantly impact public health and reduce health care costs,” Lilly CEO David Ricks said during a Thursday afternoon call to review the company’s first-quarter results, released yesterday as well. “We are encouraged by this important next step in the journey to redefine obesity care.”
FDA awarded tirzepatide fast-track designation last fall which, in addition to a rolling submission, should help to expedite the review. However, Lilly isn’t taking chances. It’s using a priority review voucher (PRV), which shaves four months from the review time.
“While we think the FDA will act quickly with the fast-track designation, we want to remove any uncertainty,” explained Mike Mason, president of Lilly Diabetes, during the earnings call. “We will be using a PRV and expect that we’ll get approval as early as the end of this year.”
The company’s obesity filing in the EU is already complete and approval there is expected in the first half of next year.
Tirzepatide, approved to treat type 2 diabetes under the brand name Mounjaro and launched in Q2 2022, was also a highlight of the quarter. Mounjaro generated sales of $569 million, beating Wall Street’s consensus by $135 million. The drug’s access picture improved, with roughly 55% of scripts reimbursed in the quarter versus 40% in the last three months of 2022.
Mounjaro sales are forecast to hit $3.7 billion this year, increasing to $8.1 billion in 2024, according to an estimate by J.P. Morgan Chase. Meanwhile, the company’s total incretin franchise is projected to reach nearly $40 billion by the mid-2030s.
“With unprecedented demand for the GLP-1 category, we expect production capacity to be a key gating factor for sales growth,” JPM’s Chris Schott wrote in a note to investors Thursday.
To that end, the company’s new manufacturing facility in North Carolina, set to double capacity, is coming on-line later this year and should help in that regard. Intermittent shortages, compounded by widespread off-label use, have made Mounjaro and other drugs in the GLP-1 class – namely Novo Nordisk’s Ozempic – hard to get.
Lilly would not confirm whether tirzepatide will be marketed for weight loss in the U.S. under a different brand name, similar to the way Novo splits branding for Wegovy and Ozempic, intended for obesity and diabetes, respectively.
Some analysts think the company is leaning toward distinct branding. Asked about the pros and cons of each, Mason cited the two-brand scenario’s “access benefits” and the ability to have “an empty vessel” for the unique promotion of an obesity indication. Merging the two makes for a more efficient supply chain and manufacturing.
Due to unforeseen high product demand and short-term manufacturing issues, Novo faced supply constraints for Wegovy that disrupted its launch. The Danish company said earlier this year that all dosage strengths of Wegovy were back in stock, which allowed the resumption of commercial activity.
“There’s just a tremendous unmet need in the obesity market,” said Mason, adding, “We’re not surprised by Wegovy’s uptake after the resupply and relaunch.”
Weight-loss data positions Eli Lilly's tirzepatide for 2023 obesity approval - MM+M Online
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