Eli Lilly cautious on using FDA fast-track voucher for weight-loss pill

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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 experimental weight-loss pill orforglipron. “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.

The FDA in July unveiled its “Commissioner’s National Priority Voucher”, under which certain experimental therapies addressing a chronic public health need and meeting specific criteria could be reviewed in one-to-two months, rather than the standard ten months.

Several Wall Street analysts told Reuters this week that orforglipron could be a prime candidate for the program, given the growing cost burden of expensive injectable weight-loss drugs and the fact that Lilly is expanding its U.S. manufacturing.

Analysts forecast the pill will bring in peak annual sales of $10 billion and are expecting it to secure FDA fast-track approval by the end of 2025.

Jonsson said Lilly is obliged to study regulatory options but stressed the company’s base plan does not depend on the yet-to-be-defined voucher program. He added that 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.

Jonsson declined to specify locations for pill manufacturing outside the United States, but confirmed non-U.S. production is planned.

“We have a big (outside the U.S.) network being engaged in the manufacturing of orforglipron as well,” he said, adding that producing tablets is simpler than injectables because there is less reliance on cold chain.

Orforglipron is designed to mimic the appetite-suppressing GLP-1 hormone targeted by Lilly’s blockbuster injection tirzepatide, sold under the brand names Mounjaro and Zepbound.

Wall Street is closely watching Lilly’s launch plans for orforglipron, in part because Danish rival Novo Nordisk has also developed an oral obesity product and expects U.S. regulatory approval later this year.

(Reporting by Maggie Fick and Mrinalika Roy. Editing by Mark Potter and Sharon Singleton)