Eli Lilly Receives US Approval for New Weight-Loss Pill

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s new weight-loss pill, initiating a new phase of competition with the Danish company Novo Nordisk in the GLP-1 therapy market, Reuters reports.

The drug, orforglipron, will be marketed under the brand name Foundayo and is a once-daily oral therapy that targets the GLP-1 hormone. In clinical trials, patients taking the medication lost between 12% and 15% of their body weight.

Eli Lilly announced that sales will begin on April 6 through their direct-to-patient access platform, with prices starting at $149 per month for the lowest dose for self-funding patients. Shortly thereafter, the product will also be available in pharmacies and through telemedicine services.

The company’s CEO, David Ricks, stated that the drug is suitable for both weight reduction and maintenance of achieved results, and it has already been submitted for approval in over 40 countries.

“We expect approvals in several key markets later this year. The Gulf countries are among those that typically move faster,” Ricks said.

The approval was accelerated through a new FDA program, placing Eli Lilly back in direct competition with Novo Nordisk. The Danish company was the first to enter the market with injectable GLP-1 therapies such as Ozempic and Wegovy, but Eli Lilly currently dominates the US market. At the same time, Novo Nordisk was the first to introduce an oral form of Wegovy, which is experiencing strong demand.

An advantage of Eli Lilly’s new pill is that it can be taken at any time of day, with or without food. In contrast, the tablet form of Wegovy must be taken in the morning on an empty stomach, at least 30 minutes before food, water, or other medications.

According to analysts, this flexibility could influence patient choice, although factors such as price and side effects remain key.

Expectations are that oral medications will not completely replace injectable therapies, which lead to greater weight loss, but they could capture about 20% of the market by 2030.

In a late-stage 72-week clinical trial, orforglipron led to approximately a 12% reduction in body weight, with the effect stabilizing in most patients. An earlier 36-week study reported a reduction of nearly 15%.

The most commonly reported side effects were mild to moderate gastrointestinal complaints, including nausea and vomiting.

The drug also carries a “black box” warning—the FDA’s most serious warning—regarding an increased risk of thyroid tumors. Novo Nordisk’s Wegovy products carry a similar warning.

Approval was granted through a special accelerated procedure for drugs with a potentially significant public health impact. The FDA emphasized that despite the accelerated process, the evaluation was just as thorough as standard procedures.

“What we do is bring together the various experts within the agency who review the individual parts of the application,” explained FDA Commissioner Marty Makary.