VIENNA (Reuters) - Eli Lilly's international president said on Wednesday it was too early to assume the company would use the U.S. Food and Drug Administration's new fast-track review process for its
Eli Lilly Gains Momentum with New Data on Weight-Loss Pill Approval
By Maggie Fick and Mrinalika Roy
VIENNA (Reuters) - Eli Lilly's bid for approval for an experimental weight-loss pill got a boost on Wednesday with new clinical trial data, and the company reaffirmed that it was too soon to assume the drug will be part of a new U.S. speedy review program.
Lilly's shares rose about half a percentage point on Wednesday. Its pill, orforglipron, is designed to mimic the appetite-suppressing GLP-1 hormone targeted by the company's blockbuster injection tirzepatide, sold under the brand names Mounjaro and Zepbound.
Lilly, based in Indianapolis, has been trying to widen its lead in the fast-growing market for GLP-1 drugs over Danish rival Novo Nordisk <NOVOb.CO>. Novo was first-to-market with GLP-1 medicines Ozempic for diabetes and Wegovy for obesity but this year ousted its CEO and its share price has dropped about 40% as competition has intensified from Lilly.
Lilly said that in a head-to-head trial of adults with type 2 diabetes orforglipron lowered average blood sugar and weight more effectively than Novo's older GLP-1 pill Rybelsus.
"The data strengthens our conviction that Eli Lilly is well positioned to maintain leadership in the GLP-1 market," said Daniel Barasa, portfolio manager at Gabelli Funds. He said orforglipron not only shows superior efficacy but also advantages in dosing convenience in the trial against Rybelsus.
Full data from a different late-stage trial of the drug showed that orforglipron helped overweight people lose about 12% of their body weight, with a safety profile similar to injected drugs, Lilly said on Tuesday.
The new data "give us increased confidence in the competitive profile of orforglipron," BMO Capital Markets analyst Evan Seigerman said in a Wednesday research note.
Lilly, the world's most valuable drugmaker by market value, is expanding U.S. and international manufacturing capacity to meet soaring demand for GLP-1 treatments, as it races with Novo to get an oral version to the market for weight loss.
Novo expects a U.S. regulatory decision on its oral obesity drug candidate later this year.
Several Wall Street analysts have suggested that orforglipron could be a candidate for the U.S. Food and Drug Administration's new priority voucher that shortens reviews for certain therapies that address major public health needs, but executives at Lilly signalled caution.
"There is very little knowledge about this national priority voucher today. I would not assume we will submit with a national priority voucher, because we do not fully understand what it contains," Patrik Jonsson, president of Lilly International, told Reuters in an interview on Wednesday.
Kenneth Custer, president of Lilly Cardiometabolic Health, repeated the company's earlier statement that it is too early to know how the program might apply to Lilly's pipeline.
Lilly has said it plans to seek regulatory approval of orforglipron for weight-loss this year and will file for approval of the drug as a diabetes treatment next year.
Jonsson said Lilly plans to file for approval of orforglipron with regulators in the United States, Britain, European Union, Japan and China "within weeks" of each other.
He declined to specify locations for pill manufacturing outside the U.S., but confirmed non-U.S. production is planned.
The drug is forecast by analysts to generate peak annual sales as high as $10 billion.
(Reporting by Maggie Fick, Sriparna Roy, and Mrinalika Roy; additional reporting by Deena Beasley in Los Angeles. Editing by Mark Potter, Sharon Singleton, Chizu Nomiyama and David Gregorio)
