Foundayo: Lilly's weight-loss pill wins US approval

The US. FDA on Wednesday ​approved Eli Lilly’s weight-loss pill, setting up the next battle with Novo Nordisk for the millions of Americans seeking highly effective ‌GLP-1 medicines.

The Lilly drug, orforglipron, which will be sold under the brand name Foundayo, is a once-daily oral medication that targets the GLP-1 hormone. Patients taking the drug in trials lost 12% to 15% of their body weight.

Lilly said it will begin selling Foundayo on April 6 through its LillyDirect program at a cost of $149 per month for the lowest dose ​for self-pay customers, on par with Novo’s pill. Soon after, it will be available through retail pharmacies and telehealth providers, the Indianapolis-based company ​said.

“As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world,” ⁠said Lilly CEO David Ricks in a statement.

LILLY VS NOVO

The approval, fast-tracked under the Food and Drug Administration’s new voucher program, puts Lilly back in ​direct competition with Danish drugmaker Novo Nordisk.

Novo was first with its injectable GLP-1 medicines, including Ozempic for diabetes and Wegovy for obesity, but Lilly now dominates ​that US. market. Novo also gained the first-to-market advantage in pills, when it launched oral Wegovy in January to strong demand.

Lilly’s pill can be taken without any restrictions and at any time of day, compared with the Wegovy pill, which must be taken first thing in the morning and 30 minutes before any food, water or other medications.

“In the early ​innings of the launch, investors will be following closely to see if Foundayo’s lack of a food effect drives any difference in patient uptake,” BMO ​analyst Evan Seigerman said in a research note.

Shares of Lilly climbed 6%, while U.S.-listed shares of Novo fell slightly after the approval announcement.

PILLS VS INJECTABLES

Most oral Wegovy patients are ‌taking a ⁠GLP-1 for the first time, an indication that the pills can capture a share of the weight-loss market not served by injectables, said Novo Nordisk US. operations executive Jamey Millar.

Millar said oral Wegovy patients have not had issues taking the pill according to instructions and that affordability and side effects are more significant factors for patients when choosing a drug.

Oral weight-loss drugs are not expected to fully replace injectables, which can deliver greater weight loss, but analysts estimate pills ​could capture around 20% of the ​market by 2030.

In a 72-week late-stage ⁠trial, orforglipron helped overweight people lose about 12% of their body weight, with weight loss plateauing for most patients. In a previous 36-week midstage trial, orforglipron was shown to reduce body weight by nearly 15%.

The most commonly reported side effects ​were mild-to-moderate gastrointestinal issues such as nausea and vomiting.

Foundayo’s label comes with a boxed warning – the FDA’s most ​serious label addition – advising ⁠of an increased risk of thyroid C-cell tumors. Novo’s oral and injectable Wegovy carry the same warning.

Lilly’s pill was granted a voucher under the Commissioner’s National Priority voucher program, which aims to fast-track FDA decisions for drugs with critical public health or national security impact.

Lilly received the voucher as part of a deal with the Trump administration ⁠to lower ​the prices of its weight-loss medicines for government programs and cash-paying patients.

FDA Commissioner Marty Makary ​told reporters the Lilly pill review was as thorough as the traditional longer process would have been. “What we’re doing is convening the different people at the agency that review parts of the application,” ​he said.