The Ozempic and Wagovy boxes made by Novo Nordisk are seen in a pharmacy.
Hollie Adams | Reuters
The long American shortage of Novo NordiskBlockbuster weight loss injection, treatment with the treatment of diabetes and diabetes is resolved after more than two years, the United States food and medication administration said on Friday.
The FDA decision will threaten the ability to aggravate pharmacies to make much cheaper versions and without a mark of the injections in the coming months. Many patients were based on unpropped versions of Wogovy and Ozempic, since composite pharmacies can make versions of brand medications in supplies.
Novo Nordisk actions closed approximately 5% more on Friday. Meanwhile, actions of Hims and hersA telesalud company offered by Wegovy and Ozempic compound, fell more than 25%.
The active ingredient in the two injectable drugs of Novo Nordisk, Semaglutide, has been in shortages in the US. UU. Since 2022 after the demand shot. Who has forced Novo Nordisk and his rival Eli Lilly To invest a lot to expand their manufacturing traces for their respective weight loss and diabetes medications, and may be paying off.
The FDA determined that the supply and manufacturing capacity of Novo Nordisk for semaglutidal injections can now meet the current demand and projected in the US. UU., The agency said that patients and prescribers can still see “intermittent supply interruptions. and limited “as the products move through the supply offer through the offer. Pharmacies chain.
“We are pleased that the FDA has declared that the supply of semaglutidic medicines made by the FDA is resolved,” Dave Moore, executive vice president of US operations and global commercial development of Novo Nordisk, said in a statement.
He added that “no one should have to compromise their health due to erroneous information and reach false or illegitimate drugs that pose significant safety risks for patients.”
The FDA announcement occurs only a few months after the agency declared that the shortage of Tirzepaturo: the active ingredient in the injection of Eli Lilly weight loss was over the counterpart of diabetes and Mounjaro diabetes.
The FDA's decision on Friday could better position Novo Nordisk to compete with Eli Lilly in the booming weight loss drug market, which some analysts say they could use more than $ 150 billion annually after 2030.
Threat to compound medications
The agency's decision, based on an exhaustive analysis, essentially marks the end of a period in which composite pharmacies could make, distribute or dispense not approved versions of semaglutida without facing repercussions for violations related to the state of shortage of treatment.
Composite pharmacies should stop making versions composed of semaglutida in the next 60 to 90 days, depending on the type of installation, the agency said. This transition period will probably give patients to change the brand versions of medicines.
But, in accordance with the FDA rules, compounds can still make alternative versions of medications if they modify the doses, add other ingredients or change the method to give the treatment to meet the needs of a specific patient.
Some patients trust compound versions because they do not have insurance coverage for Novo Nordisk medications and cannot pay their strong prices of approximately $ 1,000 per month. While Ozempic is covered by most health plans, weight loss medications such as Wegovy are not currently covered by Medicare and other insurance.
