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Pfizer, trying to jump on the quick weight-loss bandwagon, runs into big problem

Pfizer announced on Monday that it’s halting the development of its weight loss pill Danuglipron after a trial patient suffered a liver injury.

According to a press release from Pfizer, the drug led to elevated liver enzymes in over 1,400 participants — which is completely normal for these sorts of drugs.

However, one asymptomatic trial patient suffered some sort of liver damage from the pill, prompting Pfizer to cancel all development of the drug.

“[A] single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury, which resolved after discontinuation of Danuglipron,” the press release reads.

“After a review of the totality of information, including all clinical data generated to date for Danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule,” it continues.

Danuglipron, a GLP-1 drug, was meant to work just like Ozempic but as a once-daily swallowable pill versus a once-weekly injection.

“While we are disappointed to discontinue the development of Danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients,” Pfizer’s chief scientific officer, Dr. Chris Boshoff, said in a statement.

“Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity program,” he added.

All this comes despite what had seemed like a positive trajectory for Danuglipron.

“The once-daily version of the pill was in early-stage testing, with researchers trying to figure out the best dose for patients,” PBS News notes. “The company intended to move the drug into late-stage testing, which is generally the last phase of development before a company submits the potential treatment to government regulators for approval.”

PBS News further notes that Pfizer isn’t alone in trying to develop an oral form of Ozempic. So is Eli Lilly, which has been studying “a couple” of oral treatment options.

Indeed, Eli Lilly just announced this week that its oral GLP-1 drug, Orforglipron, “demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in [its just completed,] successful Phase 3 trial.”

“We are pleased to see that our latest incretin medicine meets our expectations for safety and tolerability, glucose control, and weight loss, and we look forward to additional data readouts later this year,” Eli Lilly CEO David A. Ricks said in a statement.

“As a convenient once-daily pill, Orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world,” he added.

CNBC previously predicted that Eli Lilly’s drug may turn out to be a “game-changer.”

“Analysts expect the pill to be as effective, safe, and tolerable to take as Novo Nordisk’s semaglutide – the active ingredient in its popular but costly weight loss injection Wegovy and diabetes drug Ozempic,” CNBC reported in March.

“The trial results are among the pharmaceutical industry’s most critical and closely watched of the year, as they bring Eli Lilly’s drug one step closer to becoming a new, needle-free alternative for weight loss and diabetes,” the report continued.

Critics, meanwhile, responded to news of Pfizer dropping its own GLP-1 pill with a certain degree of shock.

Look:

Interesting point.

Another critic predicted that this is the beginning of the end for GLP-1 drugs.

“The first GLP-1 domino has fallen,” they wrote. “It’s only a matter of time before the rest fall as well. It was never sustainable when you began hearing that the weight loss efficacy was temporary. Should’ve never been allowed for weight loss to begin with.”

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Vivek Saxena
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