Lilly bags FDA okay for Wegovy pill rival orforglipron

Eli Lilly has its first approval for oral GLP-1 agonist orforglipron, in the US, where it will compete with Novo Nordisk's first-to-market Wegovy pill.

The FDA has approved orforglipron, under the Foundayo trade name, in just 50 days, thanks to a fast track review under the regulator's national priority review voucher scheme. Lilly's drug is the first new molecular entity to be approved under the programme.

Lilly said it plans to start accepting prescriptions immediately and will start shipping the drug within a week, which means Novo Nordisk's window of opportunity to build an uncontested market for oral Wegovy (semaglutide) only lasted three months.

The approval also means that, for the foreseeable future, the current Lilly/Novo near-duopoly on injectable GLP-1 agonist-based therapies for weight loss will be extended into the oral GLP-1 category.

Foundayo will initially be available for $149 at the lowest dose for cash-paying customers through Lilly's direct-to-consumer sales channel, Lilly Direct, with wider retail distribution and telehealth availability following shortly after. For people with commercial coverage, co-pays will start at $25 per month.

Lilly's monthly self-pay cost is set at the same level as the starting cost of the Wegovy pill. The highest dose of Foundayo has been set at $349 per month – which can be reduced to $299 if patients refill their prescriptions within a 45-day window.

Lilly is emphasising that Foundayo can be taken any time of day, without food or water restrictions, seeking an edge over oral Wegovy, which has to be taken first thing in the morning on an empty stomach, half an hour before eating or drinking. Some data also suggests a lower rate of gastrointestinal side effects, the main tolerability issue with GLP-1-acting drugs.

Novo Nordisk, meanwhile, has alluded to a slightly higher efficacy in trials for its pill that rivals injectable Wegovy – with the usual caveat of trying to compare studies with different protocols – along with the strong familiarity with the brand, and proven cardiovascular benefits with semaglutide.

Ultimately, the contest could come down to commercial reach and marketing muscle, and both Lilly and Novo Nordisk have been working hard to develop a network of third-party providers, targeting both individuals and company health plans, to boost patient access.

Earlier this week, Novo Nordisk also launched a service offering further discounts in return for signing up for three-, six- and 12-month subscriptions to Wegovy, cutting the monthly self-pay cost to between $249 and $329.

There's little doubt that greater access to an oral alternative will also grow the market for weight-loss therapies among people who might baulk at having to administer weekly injections.

"Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn't serious enough for treatment," said Lilly chief executive David Ricks.

"We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications," he added. "As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world."