Pfizer’s twice-daily weight loss pill joins a long list of obesity drug flops
Pfizer’s twice-daily weight loss pill joins a long list of obesity drug flops


Sopa Images | Lightrocket | Getty Images

Pfizer’s twice-daily model of its experimental weight loss pill has now joined a long list of other scrapped drugs that aimed to deal with obesity however got here with unintended penalties. 

The drugmaker on Friday mentioned it can cease growing the twice-daily remedy, danuglipron, after overweight sufferers taking the drug misplaced important weight however skilled excessive charges of opposed uncomfortable side effects in a midstage scientific trial. Pfizer famous that it’ll launch knowledge on a once-daily model of the pill subsequent yr, which can “inform the trail ahead.” 

The announcement got here six months after Pfizer scrapped a totally different once-daily pill in June, citing elevated liver enzymes. Pfizer’s transfer to drop two obesity drug candidates in simply a few months demonstrates how tough it’s to develop an efficient, protected and tolerable remedy for dropping weight, even after latest breakthrough medicines entered the area. 

That contains Novo Nordisk‘s Wegovy and diabetes remedy Ozempic in addition to Eli Lilly‘s diabetes drug Mounjaro. They have all skyrocketed in recognition — and slipped into shortages — over the past yr for safely and efficiently inflicting important weight loss. An estimated 40% of U.S. adults are overweight, making these medication the pharmaceutical business’s latest money cow. 

But earlier than the present weight loss business gold rush, the trail to treating obesity was strewn with failures relationship again a long time.

The important purpose many experimental remedies have been scrapped by drugmakers, rejected by U.S. regulators or finally pulled from the market have been unintended uncomfortable side effects, together with elevated liver enzymes, most cancers dangers, cardiovascular dangers and critical psychiatric issues, resembling suicide. 

Eisai’s lorcaserin

One of the newest casualties amongst experimental obesity medication is Japanese drugmaker Eisai’s lorcaserin, which was removed from the market in 2020 as a result of inflicting an elevated threat of most cancers in sufferers. 

The Food and Drug Administration greenlit lorcaserin in 2012 primarily based on a number of scientific trials however required Eisai to conduct a bigger and longer examine on the drug after the approval.

That examine on about 12,000 sufferers over 5 years discovered that extra individuals taking lorcaserin have been diagnosed with cancer in contrast with these taking a placebo, which led the FDA to tug the drug from the market.  

Lorcaserin, marketed beneath the model identify Belviq, did not seem to realize a lot traction whereas it was commercially accessible. In its full-year 2019 earnings, Eisai reported that Lorcaserin had gross sales of $28.1 million within the U.S. for the yr. Global gross sales of the drug have been about $42 million. Eisai’s whole gross sales for the yr have been roughly $4.42 billion.

Sanofi’s rimonabant

An obesity drug known as rimonabant from Sanofi and Aventis was withdrawn from all markets in 2008 as a result of threat of critical psychiatric issues, together with suicide. 

Notably, the remedy by no means gained approval within the U.S. as a result of a panel of consultants to the FDA rejected the drug amid fears that it might trigger suicidal ideas. But European regulators permitted rimonabant, marketed beneath the identify Acomplia, in 2006 primarily based on intensive scientific trials. 

Two years later, European regulators beneficial the suspension of rimonabant after one of its committees decided that the dangers of the remedy — significantly psychiatric points — outweighed its advantages. 

The remedy suppressed urge for food by blocking the receptor of cannabinoid substances within the mind, which performs an necessary position in regulating the physique’s meals consumption and metabolism. 

Due to rimonabant’s restricted time available on the market and failure to win U.S. approval, the drug by no means reached Sanofi’s lofty projection that it will finally generate $3 billion a yr or extra. 

Abbott Laboratories’ sibutramine

Several obesity medication have additionally been discontinued, rejected or pulled from the market as a result of unintended cardiovascular dangers. 

That contains sibutramine from Abbott Laboratories, which was as soon as broadly used as a remedy for obesity together with weight-reduction plan and train.

The drug was first permitted in 1997, however carried warnings about hypertension and a threat of coronary heart assault and stroke in cardiovascular sufferers. 

A big, long-term trial on practically 10,000 adults confirmed that sibutramine was related to a important improve in cardiovascular occasions, which prompted regulators within the U.S. and Europe to tug the drug from these markets in 2010.

Sales of sibutramine had been dwindling forward of its removing from the market. The drug raked in solely $80 million globally, together with $20 million from the U.S., within the first 9 months of 2010.

Recent proof means that the latest slate of permitted weight loss medication might have the other impact on coronary heart well being: Weekly injections of Wegovy slashed the general threat of coronary heart assault, stroke and loss of life from cardiovascular causes by 20%, in keeping with a recent clinical trial



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *