Eli Lilly wins UK MHRA approval for Foundayo weight-loss pill

UK—Eli Lilly has secured UK approval for Foundayo (orforglipron), its once-daily oral GLP-1 medicine for weight management and type 2 diabetes, making the country the first in Europe to authorize the treatment for both conditions.

The approval from the Medicines and Healthcare products Regulatory Agency (MHRA) marks another milestone in the rapidly growing market for oral weight-loss medicines.

However, the regulator clarified that Foundayo is not yet available through the National Health Service (NHS).

Before NHS reimbursement can be considered, the treatment must undergo a cost-effectiveness assessment by the National Institute for Health and Care Excellence (NICE).

According to an Eli Lilly spokesperson, Foundayo will become available later this month through private prescriptions in the UK.

The company also confirmed that the medicine will carry a lower private list price than Mounjaro, which is currently priced at £330 (US$446) for a month’s supply. Lilly has not yet disclosed the exact price of Foundayo.

Competition in the oral GLP-1 market intensifies

The approval comes just two months after Novo Nordisk secured UK authorization for its oral Wegovy tablet, making Foundayo only the second GLP-1 weight-loss pill available in the European market.

Lilly is also awaiting a regulatory decision in the European Union, where Foundayo remains under review.

Meanwhile, Novo’s Wegovy pill has already received a positive opinion from the European Medicines Agency, with final approval now pending from the European Commission.

For years, injectable GLP-1 therapies from Lilly and Novo Nordisk have dominated the weight-loss market.

However, pharmaceutical companies are increasingly investing in oral alternatives to broaden patient access.

Although demand for tablets is growing quickly, injectable medicines continue to lead the market because of their proven effectiveness and convenient once-weekly dosing.

Convenience drives Lilly’s strategy

Lilly is positioning Foundayo as a more convenient option for patients.

Unlike Novo’s oral Wegovy, which must be taken first thing in the morning on an empty stomach with a small amount of water, and then a 30-minute wait before eating, drinking, or taking other medicines, Foundayo can be taken once daily without any food or water restrictions.

Despite this advantage, Foundayo has experienced a slower commercial rollout in the United States since its April launch.

During the second quarter, the medicine generated US$98 million in sales, while Novo’s oral Wegovy has benefited from greater physician familiarity because it contains semaglutide, the same active ingredient used in the company’s injectable products.

Lilly Chief Executive David Ricks has attributed Foundayo’s slower uptake to the fact that it is an entirely new medicine that requires time to build confidence among healthcare providers and patients.

Meanwhile, both Lilly and Novo Nordisk maintain that oral GLP-1 therapies are expanding the overall obesity treatment market by attracting new patients rather than simply replacing injectable medicines.