The day after the U.S. Food and Drug Administration (FDA) approved Eli Lilly's oral obesity drug "Poundayo," Novo Nordisk moved to respond by immediately releasing comparative data.
On the 2nd (local time), Novo announced results from an indirect comparative analysis indicating that the oral Wegovy (oral semaglutide) is superior to Poundayo in weight-loss efficacy and tolerability. To date, there has been no head-to-head clinical trial comparing Poundayo with the Wegovy tablet.
Some interpret the announcement as reflecting the company's sense of urgency. According to Macquarie Capital, despite rapid early uptake, the Wegovy tablet's weekly prescription growth rate slowed from the 20%–30% range to around 5% in mid last month.
On the 1st, Lilly shares rose about 4%, while Novo shares fell more than 1%.
◇ "Wegovy tablet cuts 3 percentage points more than Poundayo… discontinuation due to side effects also lower"
Novo conducted a population-adjusted indirect treatment comparison (ITC) using the results of each phase 3 trial. The comparison was between the Wegovy tablet's "OASIS-4" trial and Poundayo's "ATTAIN-1" trial.
The analysis was conducted after adjusting for baseline weight, glycemic status, sex, and other factors. The results will also be presented at the Obesity Medicine Association (OMA) annual meeting in San Diego, U.S., on the 10th–12th.
According to Novo, the Wegovy 25 mg tablet showed an average weight-loss effect about 3 percentage points higher than Poundayo 36 mg.
The FDA approved Poundayo at doses up to 17.2 mg. Novo said that dose is equivalent to the 36 mg capsule used in clinical trials.
Differences also appeared in treatment discontinuation rates due to adverse events. The likelihood of discontinuation due to any adverse event was about four times higher for Poundayo than for Wegovy, and the likelihood of discontinuation due to gastrointestinal side effects was about 14 times higher.
Poundayo restricts use in some patients taking the hyperlipidemia treatment "simvastatin" and in patients co-administered with cytochrome P450 3A4 (CYP3A4) inducers.
However, Novo noted as limitations that the analysis compares different clinical trials and that the number of adverse events was small.
◇ "Restrictions on fasting administration have little impact"… 84% of obesity patients choose "Novo treatment conditions"
Novo also released a separate patient preference survey. The survey was conducted on 800 overweight or obese adults in Oct.–Nov. last year.
According to the results, 84% of overweight/obese adults preferred the oral semaglutide treatment profile (conditions), including efficacy, side effects, and dosing method.
Despite the strict dosing requirements, patient acceptability was high. The Wegovy tablet must be taken in the morning on an empty stomach with no more than 4 ounces (about 120 ml) of water, followed by avoiding food intake for at least 30 minutes. Poundayo has no such restrictions.
Novo added, "Sixty-five percent of respondents said the 30-minute wait after fasting administration would not significantly affect daily life."
Jamie Miller, vice president of Novo's North America business unit, said, "Semaglutide continues to demonstrate clinical competitiveness," and "we also confirmed that patients place importance on treatment options that fit their lifestyle patterns."
◇ BofA cuts Poundayo sales outlook… "In the end, it's a battle over insurance and prescription channels"
Based on Novo's announcement, Jason Gerberry, an analyst at Bank of America (BofA), lowered Poundayo's sales forecast for this year from $3 billion to $2 billion.
However, he projected that Lilly's share price would remain resilient even after the Poundayo launch. He said the recent weakness was due to concerns about the size of the glucagon-like peptide-1 (GLP-1) market and drug pricing.
In an investor note, he said, "Early launch trends are likely to unfold similarly to the Wegovy tablet case," adding, "Poundayo may secure relative price competitiveness, but Wegovy enjoys a first-to-market advantage."
Macquarie Capital viewed insurance coverage and prescription channel strategy as key variables in the competitive landscape ahead.
Macquarie Capital said, "The Wegovy tablet has a slight edge in weight-loss efficacy and side effects, while Poundayo has strengths in dosing convenience and manufacturing efficiency," adding, "Ultimately, insurance coverage, direct-to-consumer (DTC) strategy, and prescription data will determine competitiveness."
Lilly began accepting prescriptions the day before through its online platform "LillyDirect" and plans to start deliveries on the 6th. It also plans to expand supply through U.S. pharmacies and telemedicine platforms.