Ozempic and Wegovy boxes made by Novo Nordisk can be found at the pharmacy.
Holly Adams | Reuters
Long-term US shortage Novo NordiskThe US Food and Drug Administration said Friday that the blockbuster weight loss wegovy and diabetes treatment ozempic were resolved more than two years later.
The FDA decision threatens the ability of pharmacies to create much cheaper, non-branded injected versions over the coming months. Many patients relied on unapproved versions of Wegovy and Ozempic. Because the pharmacies that formulate are allowed to run out of versions of branded drugs.
Novo Nordisk shares rose about 5% on Friday. Meanwhile, stocks of Hims & HersTelehealth companies offering combined Wegovy and Ozempic have fallen by more than 25%.
Both active ingredients of Novo Nordisk’s injectable drug Semaglutide have been in short supply in the US since 2022 after demand skyrocketed. It forced Novo Nordisk and its rivals Eli Lily It could be rewarding as you invest heavily in expanding your manufacturing footprint for each weight loss and diabetes medication.
The FDA has determined that Novonordisk’s supply and manufacturing capacity for semaglutide injections can meet current and projected demand in the United States, and the agency said it would “seek” as patients and prescribers pass the supply. He said there is still a disruption in intermittent and limited local supply. Chain to pharmacies.
“We are pleased that the FDA has declared that the supply of only actual FDA approved semaglutide drugs will be resolved,” Dave Moore, executive vice president of US operations and global business development at Novo Nordisk, in a statement. .
He added, “There is no need to compromise on health due to misinformation and reach for fake or illegal imitation drugs that pose a significant safety risk to patients.”
The FDA announcement comes just a few months after the agency declared a lack of tilzepatide (Elilyrie’s weight loss infusion Zepbound and the active ingredient in the corresponding Moonjaro in diabetes).
FDA decision on Friday said it would be worth more than $150 billion a year since 2030, some analysts say Novonordisk will be better off competing with Elirily in the booming weight loss drug market You can position it.
Threats to combined drugs
Institutional decisions based on a comprehensive analysis essentially create, distribute, or distribute unapproved versions of semaglutide without the consequences of violations related to lack of treatment status. It indicates the end of a possible period.
Depending on the type of facility, over the next 60-90 days, pharmacies formulating must stop producing the combined version of semaglutide in the next 60-90 days, the agency said. That transition period could allow patients time to switch to the branded version of the medication.
However, in accordance with FDA rules, compounds can be used to change doses, add other ingredients, or change the way in which treatment is given to meet the needs of a particular patient. You can create it.
Some patients rely on the compound version because they don’t have Novo Nordisk’s drug coverage and can’t afford a large price tag of about $1,000 a month. Ozempic is covered by most health plans, but weight loss medications such as Wegovy are not currently covered by Medicare or other insurance.
