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Lilly gains from weight loss pill data to consider a faster approval in the US

Eli Lilly’s bid to get approval for a weight-loss experiment got a boost Wednesday thanks to new clinical trial results. The company also reaffirmed it is too early to assume that the drug will become part of the new U.S. rapid review program.

Lilly's stock rose by about half a percent on Wednesday. Orforglipron is a pill that mimics the GLP-1 hormone, which suppresses appetite, and targets the blockbuster tirzepatide injection, sold under brand names Mounjaro or Zepbound.

Lilly of Indianapolis has been trying hard to increase its lead over Danish competitor Novo Nordisk in the rapidly growing market for GLP-1 medications. Novo Nordisk was the first to market with GLP-1 drugs Ozempic and Wegovy, both for diabetes. This year it fired its CEO and saw its share price drop by 40% due to increased competition from Lilly.

Lilly reported that in a comparison of Novo's Rybelsus, an older GLP-1 drug, orforglipron reduced average blood sugar levels and weight better than Novo Rybelsus.

Daniel Barasa said, "The data reinforces our conviction that Eli Lilly will maintain its leadership in the GLP-1 Market." He said that orforglipron, in addition to being superior in terms of efficacy, also offers advantages in terms of dosing convenience.

Lilly announced on Tuesday that the full data from another late-stage study of orforglipron showed it helped overweight people to lose about 12 percent of their bodyweight, with a similar safety profile as injected drugs.

Evan Seigerman, BMO Capital Markets' analyst, said that the new data gave him "increased confidence" in orforglipron's competitive profile.

Lilly, the most valuable drugmaker in the world by market value is expanding its U.S. manufacturing capacity and expanding it internationally to meet the soaring demand of GLP-1 treatments. It's also racing with Novo for an oral version for weight loss.

Novo anticipates that the U.S. will make a regulatory decision about its oral obesity drug candidate in later this year.

Wall Street analysts suggested that orforglipron might be a good candidate for the new priority voucher of the U.S. Food and Drug Administration, which shortens review times for therapies that are addressing major public health issues. However, executives at Lilly expressed caution.

There is very little information about the national priority voucher available today. "I would not expect that we will submit a national priorit voucher because we don't fully understand what it includes," Patrik Jönsson, the president of Lilly International said in an interview Wednesday.

Kenneth Custer is the president of Lilly Cardiometabolic Health. He reiterated the statement made by the company earlier that it was too early to tell how the program could apply to Lilly’s pipeline.

Lilly plans to file for orforglipron approval as a treatment for diabetes next year. The drug will be approved for weight loss this year.

Jonsson stated that Lilly will file applications for orforglipron approval with regulatory agencies in the United States of America, Britain, European Union (EU), Japan, and China within "weeks" of one another.

He refused to disclose the exact location of manufacturing for pills outside the U.S. but confirmed that non-U.S. manufacture is planned.

Analysts predict that the drug will generate sales of up to $10 billion in its peak year. Reporting by Maggie Fick and Sriparna Roy. Additional reporting by Deena B. Beasley, Los Angeles. Mark Potter, Sharon Singleton and David Gregorio edited the story.

(source: Reuters)