Novo Nordisk needs the Meals and Drug Administration (FDA) to stop compounding pharmacies from manufacturing their very own variations of the corporate’s widespread weight reduction drug Wegovy and diabetes remedy Ozempic, arguing the medication are too advanced for the pharmacies to make safely.
Compounded anti-obesity medication are bought at vastly decrease costs than the branded variations and may give sufferers wanted entry to medication which are in scarcity.
Ozempic and Wegovy price about $1,000 per thirty days with out reductions, and lots of insurance coverage don’t extensively cowl the medication for weight reduction functions. Semaglutide, the lively ingredient in each, has been in scarcity for greater than two years.
However Novo Nordisk requested the FDA so as to add semaglutide to a listing of “complex medications” that compounders usually are not allowed to make, no matter shortages, pointing to potential security dangers.
“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits,” the drugmaker stated in a press release.
The FDA has not but made a last choice.
Novo Nordisk stated its request “is a significant step towards keeping people safe from unapproved and potentially harmful versions of knock-off ‘semaglutide’ drugs” and that the corporate needs to “ensure that patients receive only FDA-approved, safe, and effective semaglutide products.”
It cited a number of dangers with compounded variations of semaglutide, together with unknown impurities, incorrect dosage strengths and cases the place a compounded product contained no semaglutide in any respect.
The Danish firm’s request comes as it really works to ramp up provide within the U.S. in response to skyrocketing demand. It additionally represents an escalation of efforts to crack down on clinics, compounding pharmacies and different producers promoting what it alleges are unsafe knockoff variations of semaglutide.
Compounded variations of semaglutide usually are not authorized by the FDA, and the company earlier this month stated they will pose a threat to sufferers.
The Alliance for Pharmacy Compounding was fast to notice that hostile occasions reported by sufferers taking compounded variations of the drug “are remarkably similar to those reported by patients taking the FDA-approved version.”
In a press release, the group’s CEO Scott Brunner requested why, if Novo Nordisk was so concerend about affected person security, it took the corporate two and a half years into the scarcity to appoint semaglutide to FDA’s advanced medicine lists.
“To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument,” Brunner stated.
“Novo’s ridiculous claims to the contrary, compounding pharmacies are dispensing compounded versions of those life-enhancing drugs to hundreds of thousands of patients. I get that Novo doesn’t like it, but the answer is not to restrict patient access … it’s for [Novo] to fix its supply chain,” he added.
