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Novo Nordisk, the Danish drug maker whose fortunes have soared on the recognition of its GLP-1 agonist medicine, scored a long-sought label enlargement for its weight-loss drug Wegovy on Friday, with FDA approving it to cut back the danger of main cardiovascular occasions in adults who’re overweight or obese and have established heart problems.
The approval is predicated on a virtually five-year-long examine by which once-weekly injections of Wegovy had been proven to cut back the general danger of main antagonistic cardiac occasions—together with stroke, coronary heart assault, and loss of life—by 20% in comparison with a placebo. (Wegovy lowered the danger of cardiovascular loss of life by 15%, and loss of life from any trigger by 19%.) The label enlargement is anticipated to broaden insurance coverage protection for the drug, which introduced in gross sales of about $4.5 billion final yr regardless of persistent provide shortages.
First authorized for weight reduction in June 2021, Wegovy comprises the identical lively ingredient as Ozempic—an engineered peptide known as semaglutide—however at a better dosage. In medical trials, the imply (common) weight reduction in sufferers taking Wegovy was almost 15%. However the drug’s excessive retail worth—usually greater than $1,000 per thirty days earlier than insurance coverage or producer rebates—and the reluctance of many well being insurers and employer well being plans to cowl the medicine for weight reduction, has made them inaccessible for a lot of, and pushed a thriving grey marketplace for knockoff medicine.
The expanded indication for heart problems could possibly be a sport changer, although. Whereas the need to shed pounds could also be seen by some as mere vainness, it’s laborious to argue in opposition to overlaying the price of a drug that considerably cuts the danger of coronary heart assault, stroke, and untimely loss of life. Coronary heart illness is the main explanation for loss of life within the U.S. Many analysts estimate the worldwide marketplace for cardiovascular medicine to strategy or surpass $200 billion by 2032.
The brand new indication places Novo Nordisk forward of its important rival, Eli Lilly, whose weight-loss drug Zepbound—which confirmed barely higher efficacy than Wegovy in trials—bought FDA approval in November 2023. However the firm must get on high of its provide chain points. Final yr, Novo needed to briefly halt new prescriptions for Wegovy because it struggled to maintain up with demand. Whether or not the corporate can deal with a brand new surge in prescriptions will rely upon how shortly it will possibly ramp up manufacturing. Novo introduced multibillion-dollar investments final fall to improve manufacturing websites in Denmark and France; and in February, its mother or father firm, Novo Holdings, paid $16.5 million to amass producer Catalent, which has been the principle contractor filling and packaging syringes and injection pens for Wegovy.
Novo Nordisk is pursuing extra indications past coronary heart illness, too—together with in liver and kidney illness, Alzheimer’s illness, and osteoarthritis. It’s additionally engaged on its subsequent anti-obesity blockbuster. The corporate just lately launched a Section 3 trial of a mixture drug known as CagriSema, pitting it in opposition to Lilly’s Zepbound. And on Thursday final week, the day earlier than the FDA announcement, Novo shared outcomes of a Section 1 trial of an experimental weight-loss drug known as amycretin.
Within the examine, an oral formulation of CagriSema was related to a imply change in physique weight of 13.1% at 12 weeks—greater than twice the load loss skilled with Wegovy in the identical period of time. The info despatched Novo’s refill greater than 8% for the day. The corporate expects to have the ability to launch the drug this decade—and CEO Lars Fruergaard Jørgensen has been good to his phrase thus far, sticking new drug approvals as promised and incomes his 13% elevate final yr.
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