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Drugmakers are jockeying to capitalize on the subsequent major innovation coming to the blockbuster weight reduction industry: effective, convenient and potentially reasonably priced obesity pills.
An estimated 40% of U.S. adults are obese, making a successful pill a large opportunity.
It’s too early to crown a winner, especially since pivotal data from several pharmaceutical corporations is slated to come back out later this yr. And there is still the all-important issue of pricing for the main players.
But for now, one experimental oral drug from Eli Lilly appears to have an edge over pills from Novo Nordisk and Pfizer — regardless that it might not win U.S. approval first.
All three manufacturers are developing oral versions of GLP-1s, a category of drug that mimics a hormone produced within the gut to suppress an individual’s appetite. Novo Nordisk’s popular Wegovy and Ozempic treatments, which sparked a weight reduction industry gold rush last yr, are weekly GLP-1 injections also often called semaglutide.
The pills are easier to fabricate than injections, which are available the shape of single-use pens. Meaning the oral drugs could potentially help alleviate the supply shortages plaguing their injectable counterparts.
Pills are also typically cheaper than injections, though it’s unclear if that can be the case with the obesity pills.
Wegovy’s list price tops $1,300 per monthly package, and Ozempic’s is about $935. Novo Nordisk has a low-dose oral version of semaglutide that has the identical list price as Ozempic for a monthly package of 30 tablets. That pill, marketed as Rybelsus, is approved just for Type 2 diabetes.
Not one of the three drugmakers has provided estimates for the way much the brand new obesity pills would cost.
Novo Nordisk has one vital advantage: The Danish company has already released phase three clinical trial results for its high-dose version of oral semaglutide, which is meant for weight management, and told CNBC it expects to file for Food and Drug Administration approval later this yr.
Eli Lilly continues to be in the midst of phase three clinical trials on its oral drug, orforglipron, meaning it’s more likely to hit the market later.
Still, analysts are confident within the competitive fringe of orforglipron in the long term, especially after Eli Lilly unveiled phase two clinical trial results last week that showcased the drug’s strong efficacy profile.
Strong efficacy profile
In keeping with Eli Lilly’s phase two results, obese or obese patients who took 45 milligrams of orforglipron once a day lost as much as 14.7% of their body weight after 36 weeks. That compares with a weight reduction of two.3% for individuals who received a placebo.
Eli Lilly’s results appear consistent with the load reduction brought on by Novo Nordisk’s pill, but were achieved over a shorter trial period.
Chubby or obese patients who took 50 milligrams of Novo Nordisk’s drug once a day saw a mean weight reduction of 15.1% after 68 weeks, in line with phase three clinical trial results released Sunday.
Bank of America analyst Geoff Meacham said in a Sunday research note that Eli Lilly’s available orforglipron data “compares quite favorably” to Novo Nordisk’s oral semaglutide, “cross trial comparison caveats aside.”
Cantor Fitzgerald analyst Louise Chen told CNBC that orforglipron could potentially achieve a fair greater level of weight reduction over an extended trial period.
“The more you employ these drugs, the more weight reduction you will see until it plateaus, right?” Chen said. “So the thought is, should you’re getting pretty near semaglutide’s weight reduction in almost roughly half the time with orforglipron, you’ll likely exceed it.”
Chen said the hope is that orforglipron results in a discount much like that of Eli Lilly’s injection tirzepatide, which resulted in weight reduction of around 22% after 72 weeks.
The corporate’s phase three clinical trials on orforglipron will study the drug over longer time periods.
Not less than for now, analysts say Eli Lilly’s pill can also have the upper hand over Pfizer’s oral GLP-1, danuglipron, which continues to be in phase two clinical trials.
Patients with Type 2 diabetes who took a 120-milligram version of danuglipron twice a day lost around 10 kilos on average after 16 weeks, in line with results from one phase two clinical trial.
It’s difficult to check danuglipron’s efficacy with that of other oral GLP-1s attributable to differing patient populations and the shortage of longer-term data on the drug.
A Pfizer spokesperson told CNBC that the corporate continues to be studying the drug in further phase two clinical trials and “would also look to have longer data” beyond the 16-week mark in the long run.
Ease of use
Wells Fargo analyst Mohit Bansal said in a research note that Pfizer’s danuglipron can be challenged to compete within the oral GLP-1 space given Eli Lilly’s strong orforglipron data.
He added that physicians generally prefer once-daily pills — like orforglipron — over twice-daily drugs corresponding to danuglipron.
Health experts appear to agree: “Patient compliance increases quite a bit if it is a once-a-day pill, so it’s definitely an enormous advantage. People often find yourself missing a couple of times every week in the event that they should take something twice a day,” said Dr. John Yoon, an endocrinology professor at UC Davis Health.
Pfizer is developing a once-daily version of danuglipron.
The corporate on Monday also said it could stop developing one other experimental pill, lotiglipron, which Bansal said had been the “more attractive GLP-1” in Pfizer’s portfolio because it’s only taken once a day. Shares of Pfizer fell 5% on Monday following that news.
But Pfizer and Eli Lilly do share one key advantage over Novo Nordisk’s oral semaglutide: no dietary restrictions.
Patients must take Novo Nordisk’s oral semaglutide within the morning on an empty stomach with not more than 4 ounces of plain water, in line with the FDA label for the low-dose, approved version of the drug. They’re instructed to attend half-hour before eating, drinking or taking other oral medicines.
That is because Novo Nordisk’s oral semaglutide is a peptide medication, which is tougher for the gut to soak up, in line with Dr. Eduardo Grunvald, medical director for UC San Diego’s Center for Advanced Weight Management.
“In the event you take it with food or drink, it just won’t get absorbed efficiently,” Grunvald told CNBC.
He said pills from Eli Lilly and Pfizer are non-peptide GLP-1s, that are absorbed more easily and do not require dietary restrictions.
Cantor Fitzgerald’s Chen said market research suggests that those restrictions are a “big negative for patients,” making the pills from Eli Lilly and Pfizer convenient alternatives.
Overall, Eli Lilly’s orforglipron appears to be the highest contender in the load loss pill space attributable to its strong efficacy data and convenience as a once-daily pill without dietary restrictions.
But Chen emphasized that the info unveiled later this yr could potentially change that: “Avoid wasting room for the brand new data coming.”
For health experts corresponding to Grunvald, naming a winner within the oral weight reduction drug space is less vital.
“I feel these oral GLP-1s mean having more tools in our toolbox, having more options for various individuals who might react in a different way to different medicines,” he said. “That is really the long run of this all.”