Lilly weight-loss pill could be FDA-approved by year-end

By Deena Beasley

(Reuters) -Eli Lilly's experimental weight-loss pill could be fast-tracked under a one- to two-month review process recently launched by the U.S. Food and Drug Administration, several Wall Street analysts said.

Analysts speculate that the drug, orforglipron, is a viable candidate given the growing cost burden of expensive injectable weight-loss drugs and the fact that Lilly is expanding its U.S. manufacturing - issues the Trump Administration has prioritized.

Lilly, based in Indianapolis, declined to comment.

The FDA is reviewing an oral version of Denmark-based rival Novo Nordisk's GLP-1 obesity drug, with a decision expected in the fourth quarter.

Goldman Sachs recently estimated that if orforglipron were to launch one quarter earlier than expected, it would bring in another $1 billion in revenue to Lilly.

The FDA in July detailed terms of its new "Commissioner's National Priority Voucher," under which an experimental drug meeting certain criteria could be approved within a month or two. The agency's standard review takes 10 months.

"FDA policymakers have tried to come up with ideas to speed important products to market. ... It is in part directed to achieving some of the (Trump) Administration's goals," said Chad Landmon, chair of Polsenelli's patent and FDA practice.

The program is part of the FDA's push to streamline drug reviews and, if new competition results in lower prices, aligns with President Donald Trump's goal of reducing pharmaceutical prices in the United States, which pays the most in the world.

Lilly's injected weight-loss drug - with an estimated net price of nearly $8,000 a year - and similar drugs from Novo Nordisk pose a cost burden in the United States, where about 40% of adults are obese. Employers and health insurers have cited the spending as unsustainable.

"We think orforglipron is a prime candidate for this pilot program as it treats a high-burden chronic condition and can be priced at parity," Jefferies analyst Akash Tewari said in a recent research note. He referred to the idea of a worldwide price for the drug, rather than the industry's usual strategy of pricing at a premium in the United States.

The new FDA program is "a perfect fit" for Lilly's pill, according to Citi Research analyst Geoffrey Meacham.

The FDA, which declined to comment, has said it would issue five of the new nontransferable vouchers in 2025. 

To be eligible, the agency said applications need to support at least one of five objectives: address a U.S. public health crisis; deliver innovation; address a large unmet medical need; onshore drug development and manufacturing; or increase affordability.

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. The GLP-1 class, which includes Novo Nordisk's Ozempic and Wegovy, has enjoyed unprecedented demand in recent years, with some analysts projecting annual global sales of $150 billion by the end of the decade.

Lilly, in an emailed statement, said the new FDA program is "a promising initiative," but it was "too early to discuss how this submission pathway might relate to any of our specific programs." The company has said it plans to submit the daily GLP-1 pill for regulatory review later this year. CEO Dave Ricks told CNBC in August that Lilly expects to launch the pill around the world "this time next year."

Orforglipron was shown in a recent study to help patients lose 12.4% of their body weight. Full results from that trial will be presented this week at a meeting in Vienna of the European Association for the Study of Diabetes.

Goldman Sachs, in a recent analysis, forecast U.S. net prices for new GLP-1 obesity pills at around $400 a month. It said feedback from medical experts "points to the importance of affordability for competitive positioning" and patient access. It also said competition from new market entrants will lead to price erosion.

A recent report from the Institute for Clinical and Economic Review estimated a current U.S. net price for tirzepatide of about $664 a month. People without adequate insurance coverage can buy the drug directly from Lilly for $499 a month.

Unlike orforglipron, which is a synthetic drug, Novo's experimental obesity pill is a more difficult-to-manufacture peptide, which analysts say could give Lilly more leeway on price.

(Reporting By Deena Beasley; editing by Caroline Humer and Richard Chang)