Boxes of Ozempic and Wegovy manufactured by Novo Nordisk are seen in a pharmacy.
Hollie Adams | Reuters
The long American shortage of Novo NordiskThe success of successful Wegovy blockbuster weight loss and the treatment of diabetes is resolved after more than two years, the Food and Drug Administration announced on Friday.
The FDA’s decision will threaten the ability to compose pharmacies to make much cheaper versions and without any injections in the coming months. Many patients relied on unprecedented versions of Wegovy and Ozempic, as composition pharmacies are authorized to make versions of short -term brand medicines.
On Friday, Novo Nordisk’s shares increased by around 5%. Meanwhile, the actions of Hims and his ownAn AA TV company offering Wegovy and Ozempic, composed, dropped by around 20%.
The active ingredient of the two injectable drugs from Novo Nordisk, the semaglutide, has been shortened in the United States since 2022 after the demand for demand. It forced Novo Nordisk and his rival Eli Lilly Invest massively to extend their manufacturing fingerprints for their respective weight loss drugs and diabetes – and this can be paid.
The FDA has determined that the offer and manufacturing capacity of Novo Nordisk for semaglutide injections can now meet current demand and projected in the United States, the agency noted that patients and prescribers can still see ” Disruptions of the intermittent and limited localized offer “as the products move in the chain supply to pharmacies.
“We are delighted that the FDA has declared that the supply of semaglutide drugs approved by the FDA is resolved,” said Dave Moore, executive vice-president of Novo Nordisk of American operations and global business development, in a press release.
He added that “no one should have their health to disinformation and to make false or illegitimate launching drugs that have significant safety risks for patients”.
The FDA’s announcement comes only a few months after the agency declared the shortage of shooting – the active ingredient in the injection of weight loss of Eli Lilly Zepbounde and Diabetes Diabetes Mounjaro – Over.
The decision of the FDA decision on Friday could better position Novo Nordisk to compete with Eli Lilly on the booming market of weight loss drugs, which, according to some analysts, could be worth more than $ 150 billion a year after 2030.
Threat to aggravated drugs
The agency’s decision, on the basis of a complete analysis, essentially marks the end of a period when composition pharmacies could do, distribute or distribute undisputed semaglutide versions without facing repercussions for violations linked to the status of shortage of treatment.
Composition pharmacies must stop making versions composed of semaglutide in the next 60 to 90 days, depending on the type of installation, the agency said. This transition period will probably give patients time to switch to the brand versions of drugs.
However, in accordance with the rules of the FDA, compounds can still make alternative versions of drugs if they modify the doses, add other ingredients or modify the method of provision of treatment to meet the needs of a specific patient.
Some patients are counting on aggravated versions because they do not have a Novo Nordisk medication insurance and cannot afford their heavy price labels of around $ 1,000 per month. Although Ozempic is covered by most health plans, weight loss drugs such as Wegovy are not currently covered by Medicare and other insurance.