Eli Lilly's weight-loss pill won backing from a European drug regulator panel

Eli Lilly $LLY received a recommendation from a European Medicines Agency committee on Friday to approve its weight-loss pill Foundayo for obesity and type 2 diabetes, according to Bloomberg.

The agency's Committee for Medicinal Products for Human Use backed the once-daily tablet, also known as orforglipron. The recommendation moves to the European Commission, whose ruling usually arrives roughly two months afterward, according to Bloomberg.

Foundayo was cleared in the U.S. in April as the second pill of its kind for weight loss, following Novo Nordisk's oral Wegovy, according to Bloomberg. The Food and Drug Administration authorized the drug following an expedited review through a program for treatments considered national health priorities. Unlike Novo's pill, Foundayo does not require patients to follow rules about food or water intake.

In late-stage testing, patients on the top dose shed an average of roughly 11% of their body weight across 72 weeks, versus about 2% for patients given a placebo, according to Bloomberg.

Lilly has begun selling Foundayo in several countries abroad, among them the U.K. and United Arab Emirates, and has filed for approval in roughly 40 markets, according to Bloomberg.

"As soon as we get approvals, our plan is to launch," Lilly U.S. business chief Ilya Yuffa said at an investor conference in September, according to Bloomberg.

The initial U.S. launch fell short of what analysts had projected, according to Bloomberg. Lilly has stepped up its promotion since then, among other things running an ad starring lifestyle entrepreneur Martha Stewart. Yuffa said Lilly's drug is the pick of upwards of 30% of patients who are just beginning treatment with a weight-loss pill.

"We're starting to see some progress," Yuffa said, according to Bloomberg.

The U.K.'s medicines regulator authorized Foundayo on Aug. 10 for weight management and type 2 diabetes, making it the first European regulator to clear the pill. The tablet is approved for adults with a body mass index of 30 or above, or between 27 and 30 with at least one weight-related health condition.

Lilly launched the pill in Britain on Aug. 24 through private prescription, priced between £100 and £120 per month. At the time, the European Union had not completed its assessment of the drug. Foundayo generated $98 million in revenue for the April-to-June period after its U.S. debut, the company said.