Sopa Images | Lightrocket | Getty Images
Pfizer’s twice-daily version of its experimental weight reduction pill has now joined an extended list of other scrapped drugs that aimed to treat obesity but got here with unintended consequences.Â
The drugmaker on Friday said it can stop developing the twice-daily treatment, danuglipron, after obese patients taking the drug lost significant weight but experienced high rates of opposed unintended effects in a midstage clinical trial. Pfizer noted that it can release data on a once-daily version of the pill next yr, which is able to “inform the trail forward.”Â
The announcement got here six months after Pfizer scrapped a unique once-daily pill in June, citing elevated liver enzymes. Pfizer’s move to drop two obesity drug candidates in only a couple of months demonstrates how difficult it’s to develop an efficient, secure and tolerable treatment for reducing weight, even after recent breakthrough medications entered the space.Â
That features Novo Nordisk‘s Wegovy and diabetes treatment Ozempic in addition to Eli Lilly‘s diabetes drug Mounjaro. They’ve all skyrocketed in popularity — and slipped into shortages — over the past yr for safely and successfully causing significant weight reduction. An estimated 40% of U.S. adults are obese, making those drugs the pharmaceutical industry’s newest money cow.Â
But before the present weight reduction industry gold rush, the trail to treating obesity was strewn with failures dating back a long time.
The primary reason many experimental treatments were scrapped by drugmakers, rejected by U.S. regulators or eventually pulled from the market were unintended unintended effects, including elevated liver enzymes, cancer risks, cardiovascular risks and serious psychiatric problems, akin to suicide.Â
Eisai’s lorcaserin
One of the vital recent casualties amongst experimental obesity drugs is Japanese drugmaker Eisai’s lorcaserin, which was removed from the market in 2020 on account of causing an increased risk of cancer in patients.Â
The Food and Drug Administration greenlit lorcaserin in 2012 based on several clinical trials but required Eisai to conduct a bigger and longer study on the drug after the approval.
That study on about 12,000 patients over five years found that more people taking lorcaserin were diagnosed with cancer compared with those taking a placebo, which led the FDA to tug the drug from the market. Â
Lorcaserin, marketed under the brand name Belviq, didn’t appear to achieve much traction while it was commercially available. In its full-year 2019 earnings, Eisai reported that Lorcaserin had sales of $28.1 million within the U.S. for the yr. Global sales of the drug were about $42 million. Eisai’s total sales for the yr were roughly $4.42 billion.
Sanofi’s rimonabant
An obesity drug called rimonabant from Sanofi and Aventis was withdrawn from all markets in 2008 on account of the danger of significant psychiatric problems, including suicide.Â
Notably, the treatment never won approval within the U.S. because a panel of experts to the FDA rejected the drug amid fears that it could cause suicidal thoughts. But European regulators approved rimonabant, marketed under the name Acomplia, in 2006 based on extensive clinical trials.Â
Two years later, European regulators really useful the suspension of rimonabant after considered one of its committees determined that the risks of the treatment — particularly psychiatric issues — outweighed its advantages.Â
The treatment suppressed appetite by blocking the receptor of cannabinoid substances within the brain, which plays a vital role in regulating the body’s food intake and metabolism.Â
As a consequence of rimonabant’s limited time available on the market and failure to win U.S. approval, the drug never reached Sanofi’s lofty projection that it might eventually generate $3 billion a yr or more.Â
Abbott Laboratories’ sibutramine
Several obesity drugs have also been discontinued, rejected or pulled from the market on account of unintended cardiovascular risks.Â
That features sibutramine from Abbott Laboratories, which was once widely used as a treatment for obesity together with weight loss program and exercise.
The drug was first approved in 1997, but carried warnings about hypertension and a risk of heart attack and stroke in cardiovascular patients.Â
A big, long-term trial on nearly 10,000 adults confirmed that sibutramine was related to a big increase in cardiovascular events, which prompted regulators within the U.S. and Europe to tug the drug from those markets in 2010.
Sales of sibutramine had been dwindling ahead of its removal from the market. The drug raked in just $80 million globally, including $20 million from the U.S., in the primary nine months of 2010.
Recent evidence suggests that the most recent slate of approved weight reduction drugs could have the other effect on heart health: Weekly injections of Wegovy slashed the general risk of heart attack, stroke and death from cardiovascular causes by 20%, based on a recent clinical trial.Â
