Eli Lilly Gains Boost from New Pill Data; U.S. Fast-Track Approval Still Uncertain, Officials Say

Eli Lilly (LLY.N) on Wednesday launched a fresh bid for regulatory approval of its experimental weight-loss pill, supported by new clinical trial data. However, company executives cautioned that it would be premature to assume the drug will qualify for the U.S. Food and Drug Administration’s (FDA) new fast-track review program.

Lilly’s shares rose 0.8% during the session. The company is developing the pill as an alternative to its injectable therapies, Mounjaro and Zepbound, which are already top sellers for diabetes and weight-loss treatments. Lilly is aiming to expand its presence in the rapidly growing GLP-1 market, where it faces stiff competition from Denmark’s Novo Nordisk (NOVOb.CO).

In a head-to-head trial involving 1,698 adults with type 2 diabetes, Lilly’s oral drug, orforglipron, outperformed Novo Nordisk’s oral semaglutide, Rybelsus, in reducing both average blood sugar levels and body weight.

“These results reinforce our belief that Eli Lilly is well-positioned to maintain its leadership in the GLP-1 market,” said Daniel Barasa, portfolio manager at Gabeli Funds. He added that orforglipron not only shows better efficacy but also offers improved dosing convenience compared to Rybelsus.

As the world’s most valuable pharmaceutical company by market capitalization, Lilly is expanding its manufacturing capacity both in the U.S. and globally to meet rising demand for GLP-1 therapies, aiming to be first to market with an oral version alongside its competitor Novo.

However, Lilly executives expressed caution regarding the FDA’s new priority voucher program, which is designed to accelerate reviews for treatments addressing significant public health needs.

“There’s very little information available about this national priority voucher at this point,” Patrick Jonsson, president of Lilly International, told Reuters in an interview. “We don’t anticipate applying with this voucher because we don’t fully understand its scope.”

Kenneth Kuster, president of Lilly’s Cardiometabolic Health division, said the company views the initiative positively and supports efforts to speed up regulatory reviews. However, he emphasized that it would be too early to determine how the program might apply to Lilly’s pipeline.

Several Wall Street analysts told Reuters this week that orforglipron could be a strong candidate for the priority review program.

Analysts project annual sales of orforglipron could reach $10 billion and expect FDA fast-track approval by the end of 2025.

Jonsson confirmed that while Lilly is studying regulatory options, its core strategy does not rely on the undefined voucher program. He added that Lilly plans to submit approval applications for orforglipron in the U.S., U.K., European Union, Japan, and China “within a few weeks.”

When asked about locations outside the U.S. where the pill might be manufactured, Jonsson declined to provide details but confirmed that plans for non-U.S. production are underway.

Orforglipron is designed to mimic the appetite-reducing GLP-1 hormone and targets Lilly’s blockbuster injectable drug, tirzepatide, marketed under the Mounjaro and Zepbound brands.

Novo Nordisk expects to receive regulatory approval for its oral obesity treatment by the end of this year.