Eli Lilly obesity pill Foundayo gets the FDA green light : NPR

The Food and Drug Administration has approved drugmaker Eli Lilly’s second GLP-1 pill to treat obesity.

The new pill, Foundaio, is taken once a day and will compete with Vegovy’s pill, made by Novo Nordisk, which was approved by the FDA in December.

Patients now have the option of pills instead of injections from both makers of major obesity drugs. Pill alternatives may appeal to many patients. But the cost of drugs and the extent of insurance coverage remain barriers.

The agency rapidly approved Lilly’s obesity pill for drugs that the FDA considers a national priority. The decision to approve Foundaio took 50 days, the fastest for a new drug since 2002, the agency said.

Even though Lilly is the same company behind the blockbuster injectable obesity drug Zepbound, Eli Lilly decided not to take Zepbound’s main ingredient and make it in pill form. Instead, the company developed a new ingredient, known generically as orforgaliprone, that is not a peptide like the injectable drugs, but acts like a peptide.

This means the active ingredient is easier for the body to absorb in pill form, says Daniel Skowronski, chief scientist and product officer at Eli Lilly.

“We’ve created a small molecule chemical that penetrates your body very well,” says Skowronski. “It can mimic the effects of peptides and can be more easily taken at any time of the day without any food or water restrictions.”

Its competitor Vegovy pill is a peptide. Peptides are short chains of amino acids. The Wegovi tablet contains the same active ingredient as the injection with additional ingredients so that it can be absorbed before the peptide is broken down by stomach acid. But, unlike Foundayo, Vegovy pill has to be taken on an empty stomach and the patient has to fast for 30 minutes for it to work.

So for some people, Foundaio may be more convenient – ​​and harder to mess up.

Data from one of the Lilly clinical trials reviewed by the FDA found that patients who took the highest dose of Foundaio for 72 weeks lost an average of 27.3 pounds, or 12.4% of their body weight, while those taking a placebo lost an average of 2.2 pounds, or 0.9% of their body weight. The most common side effects were nausea, constipation and diarrhea.

Novo Nordisk came out swinging against rival Goli. Jamie Miller, executive vice president of U.S. operations for Novo Nordisk, said in a statement, “Not all GLP-1 is the same. Any reports claiming orforgliprone is more effective than the Wegovi pill for weight management are false and misleading.” “There is no head-to-head trial comparing the efficacy of orfoglipron and Wegovi pill….”

In clinical trials, the Lilly pill appeared to be slightly less effective than its competitors, although it was not tested head-to-head. How this works in the real world may be different, says Dr. Katherine Varney, obesity medical director at UVA Health in Charlottesville, Virginia.

She says she wouldn’t be surprised if her patients taking the new pill lose more weight because the pill is easier to take, especially for people with complex medical regimens or those who struggle with strict dosages. She says, “For example, this is where someone is going to have a little more advantage. So… there has to be determination.”

Lilly’s Skowronski says he hopes Foundaio will appeal to patients who find injections too big a step for them.

“I think ideally this drug would be for people who haven’t tried a weight-loss drug yet,” he says. “They’re wondering if they’re sick enough, if the disease is serious enough. Maybe they’re worried about an injection not fitting into their life.”

But Varney at UVA says his experience as a physician has shown that his patients aren’t actually put off by needles. “I can tell you in the over 1,000 patients that I have had on GLP-1 therapy, not once has needle phobia been an issue,” she says.

For his patients, the biggest barrier to receiving care has been cost. She says all of her patients who are taking the Wegovi pill versus injectable drugs are taking it because they are more affordable.

Like the Wegovi pill, the starting dose of Foundayo is $149 per month for customers who are opting out of their insurance and paying cash. For comparison, the cash price of Eli Lilly’s obesity injection Zepbound is $299 per month. Both become more expensive at higher doses, but Foundaio is cheaper.

The company has not yet released a list price, which is the starting bid for insurance and what a patient’s co-payment is typically based on.

Lilly says its insurance coverage will become clear soon. But for those with commercial coverage, co-payments with the Eli Lilly Savings Card can be as little as $25 per month. And starting in July, people with Medicare coverage may be able to get it for $50 a month. Medicaid coverage may take some more time.

As far as supply is concerned, the company has been manufacturing these pills for some time and should be able to meet the demand. Skowronski says he expects they’ll be on pharmacy shelves within “a week or two.”