| | | The Lead Brief | The Food and Drug Administration has given the green light to Eli Lilly’s GLP-1 pill orforglipron, another notch in the escalating war over market share in the weight loss medication space. The medication, which will be marketed under the name Foundayo, will serve as competition to Novo Nordisk’s oral version of its blockbuster GLP-1 weight loss medication Wegovy that the FDA approved in late December. Why it matters: Pharma industry giants are battling for a chunk of the massive weight loss market that could be valued at roughly $80 billion in the years ahead. More than one in four Americans could qualify for GLP-1 medications for weight loss purposes alone, a figure that expands when including its use to treat other conditions. Data points to the popularity of pills. Since hitting the market in January, providers have written about 600,000 prescriptions for the Wegovy pill, according to Novo Nordisk. The figures only represent the United States, as it’s not approved elsewhere. Slightly more than 36 percent of people who opted for Wegovy’s oral option hadn’t tried GLP-1 medications before, which had previously only been available in injectable form, according to an analysis published last month by health data firm Truveta. The data illustrate how a weight loss pill potentially opens up a new set of patients, which Eli Lilly CEO Dave Ricks acknowledged in a Wednesday call with reporters. “The absolute number of people that are interested in an oral pill option seems to be high,” Ricks said, pointing to the success of the Wegovy pill since its launch. “There are probably a lot of people on the sidelines who had not tried a GLP-1.” During clinical trials, people taking the highest dose of Foundayo lost an average of about 27 pounds, or 12.4 percent of their body weight, compared to just 2.2 pounds with the placebo. The drug is a separate medication from Eli Lilly’s blockbuster GLP-1 medication, tirzepatide, known as Mounjaro and Zepbound. Tirzepatide has shown to trigger more weight loss — roughly 20 percent of a person’s body weight in its highest doses — in patients. → Ricks said that the company imagines Foundayo as something that patients can take to maintain weight loss obtained through injectable GLP-1 medications or use if they don’t need to lose as much weight. Eli Lilly is also testing the medication’s efficacy in treating diabetes, sleep apnea, hypertension and other conditions that contribute to heart disease — a move that, if approved by regulators, could expand the patient population eligible for the medication. “Lily has broad ambitions here,” Ricks said. → The FDA said it approved the medication just 50 days after the agency accepted Eli Lilly’s application under an expedited approval program. Ricks said on Wednesday that the overall process took 100 days, noting that the review “was thorough and deep.” “There were no real differences other than the timescale,” Ricks said. “The FDA checks our work very carefully, and they did that in this case as well.” |