Novo Nordisk addresses off-label Ozempic use as it grapples with multiple shortages
On the heels of Wegovy supply troubles, Novo Nordisk is reporting a shortage of its diabetes treatment Ozempic which contains the same active ingredient, semaglutide.
The company told Endpoints News in an email last week that it’s experiencing “intermittent supply disruptions” for the Ozempic pen that delivers 0.25 and 0.5 mg doses of the drug, caused by “incredible demand coupled with overall global supply constraints.” On Dec. 7, the American Society of Health-System Pharmacists reported shortages affecting both the 0.25 mg or 5 mg doses, as well as the 1 mg and 2 mg doses using various pen injectors.
“The company is working to resolve the issue by early-2023,” the ASHP report stated.
While Novo Nordisk declined to confirm whether the shortages are due to off-label use of Ozempic as a weight loss treatment, it did acknowledge that some providers may be prescribing the drug for such use.
“While we recognize that some healthcare providers may be prescribing Ozempic for patients whose goal is to lose weight, it is up to the clinical discretion of each healthcare provider to choose the best treatment approach for their patients,” the company said in an email.
Ozempic was approved in 2017 for patients with Type II diabetes, and won a label expansion back in 2020 to reduce the risk of certain heart problems in Type II diabetes patients. Its sibling drug, Wegovy, also contains semgalutide at a higher dose. Wegovy was approved last June as a once-weekly injection for chronic weight management in adults, but quickly faced “unprecedented demand” on top of manufacturing issues.
Novo halted Wegovy promotions back in March as the company grappled with supply issues, and promised on its Q3 call that all dose strengths would be available by the end of the year. At the beginning of the month, ASHP listed all Wegovy dose strengths as affected by a current shortage.
While Bloomberg reported earlier today that shortages have led Novo to delay Wegovy’s launch in Europe into next year, Novo refuted those claims, adding that the launch is on track.
“We have communicated since our second-quarter and third-quarter financial reports that the first launches outside of the US would happen towards the end of 2022. We launched Wegovy in Europe (Denmark) Monday, according to plan,” the company said in an email.
Meanwhile, Ozempic has taken TikTok — and reportedly Hollywood — by storm, with some #ozempicweightloss and related videos gathering hundreds of thousands of views. Australia’s regulatory agency, the Therapeutic Goods Administration, directly linked an Ozempic shortage to off-label use for weight loss earlier this year.
“The worldwide shortage of semaglutide started to affect Australia in early 2022 when Novo Nordisk couldn’t supply enough Ozempic to meet an unexpected increase in demand due to off-label prescribing for weight loss,” the agency said in a statement last month.
Ozempic raked in about $2.3 billion last quarter, up 63% from last year, according to Novo’s Q3 results.
“We did anticipate that Ozempic would grow, just not at the pace that we are seeing,” the company said in an email. “For patients with Type 2 Diabetes, GLP-1 medicines have become well-established treatments due in part to continued innovation within the class and increased utilization.”
Fatima Stanford, an obesity medicine physician scientist at Massachusetts General Hospital, said some of her patients have struggled to fill prescriptions because of GLP1 shortages. However, she added that off-label use isn’t always what you think.
“It’s important to note that 80% of patients with Type II diabetes also have obesity. So when we talk about using it off-label for weight regulation, we’re probably treating people that would have needed it anyway, for either weight and or blood sugar dysregulation,” she said.
“Novo Nordisk does not promote, suggest, or encourage off-label use of our medicines and is committed to fully complying with all applicable US laws and regulations in the promotion of our products,” Novo said in an email. “We trust that healthcare providers are evaluating a patient’s individual needs and determining which medicine is right for that particular patient.”