Issues with a contract manufacturer have led to limited availability for semaglutide.
An important type 2 diabetes medication — also approved for weight loss indication — is in high demand which is causing limited supply in some areas.
Semaglutide (Novo Nordisk), approved by the FDA as Ozempic to treat type 2 diabetes in 20171 was cleared as the chronic weight loss management medication Wegovy in June 2021.1
When Novo Nordisk experienced a problem with a contract manufacturer in March, it began limiting doses of Wegovy, Michael Ganio, Pharm.D., senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists, told Drug Topics®.
Patients reported problems obtaining Wegovy at that time, but the American Society of Health-System Pharmacists (ASHP) has not received reports of shortages since the spring. “Supply to the United States is improving. Novo Nordisk temporarily paused production of the lower doses of Wegovy — those are the doses you need to get started…so newer patients couldn’t start with lower supplies,” Ganio said.
“From the outset of our supply constraints, the top priority for our organization has been to avoid disruption to patient care and meet the needs of patients who have started treatment with Wegovy to be able to stay on therapy,” Allison Schneider, director of media relations and issues management at Novo Nordisk, told Drug Topics®.
"We have been taking measures in support of that, including pausing promotion and advertising of Wegovy and asking health care providers to not start new patients on therapies,” Schneider added.
Novo Nordisk expects that all dose strengths of Wegovy will be available in the United States towards the end of this year, according to Schneider. “We will ensure that we have all dose strengths within our inventory before we support new patients being initiated and before we start other promotional efforts, consistent with our commitment to continuity of care,” she said.
Although supply of Ozempic in the United States has been “fairly consistent”, according to Ganio, patients in other countries are having difficulty obtaining the medication.
For example, the Australia Department of Health and Aged Care Therapeutic Goods Administration (TGA), along with health organizations in the country, issued an alert on Ozempic availability on August 4.2
Novo Nordisk notified the TGA of a Ozempic products “due to an unexpected increase in consumer demand,” the agency said. "The increased demand is due to extensive prescribing for obesity management, for which Ozempic is not indicated. The shortage is significantly affecting people using Ozempic for its approved use for type 2 diabetes.”
Novo Nordisk has advised the TGA that the intermittent availability of Ozempic will continue until the end of December 2022, according to TGA. “Health professionals are reminded to continue prioritizing the supply of Ozempic for people with type 2 diabetes,” the alert said.
“We are experiencing stronger than anticipated demand for Ozempic, which might result in intermittent availability in a limited number of markets,” Schneider told Drug Topics®. “For those affected markets, we are in a dialogue with the health authorities and other relevant stakeholders to ensure a continuous supply of products.”
Ozempic is available in the United States currently, Erin R. Fox, Pharm.D., senior pharmacy director at the University of Utah Health, which provides drug shortages data to ASHP, told Drug Topics®. However, Novo Nordisk is not “forthcoming about their supplies and exactly what is going on, so it’s impossible to speculate exactly how much is available or if more presentations will be affected, or if supplies will start to recover,” Fox said.
1. FDA approves new drug treatment for chronic weight management, first since 2014. News release. FDA. June 4, 2021. Accessed August 10, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014
2. Joint statement: Prioritisation of semaglutide (Ozempic) supply for people with type 2 diabetes during shortage. Alert. Australia Department of Health and Aged Care Therapeutic Goods Administration. August 4, 2022. Accessed August 10, 2022. https://www.tga.gov.au/alert/joint-statement-prioritisation-semaglutide-ozempic-supply-people-type-2-diabetes-during-shortage