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Faced with short-term manufacturing issues and unprecedented demand after its diabetes-related drugs became popular as a quick fix for weight loss, Novo Nordisk is working to resolve shortages of Ozempic and Wegovy by the end of the year.

The Danish multinational pharmaceutical company – which maintains its U.S. headquarters in Plainsboro – has taken several steps to minimize demand from new patients and increase the likelihood there will be enough medications available to meet the needs of current patients.

Approved in 2017 by the U.S. Food and Drug Administration, Ozempic (semaglutide) is a treatment for adults with Type 2 diabetes that is self-injected under the skin. The drug works by mimicking a natural hormone the body releases when a person eats, potentially causing weight loss as a secondary effect.

Along with diet and exercise, Ozempic can improve blood sugar and reduce the risk of major cardiovascular events, such as heart attack, stroke or death in adults with Type 2 diabetes and known heart disease.

Allison Schneider, director of media relations & issue management at Novo Nordisk, noted that Ozempic “was clinically researched and studied in patients with Type 2 diabetes” and not approved by the FDA “for chronic weight management nor is it intended to be used as a lifestyle medication.”

On the other hand, Wegovy, which also contains semaglutide, was authorized in June 2021 specifically for chronic weight management in adults who are obese or overweight with at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

The drug, which is given through injector pens, is meant to be used with a reduced-calorie meal plan and increased physical activity. It is also “not intended to be used as a lifestyle medication, nor has it been studied for this,” Schneider said.

In recent weeks, numerous media outlets reported on increased demand of Ozempic and Wegovy, particularly among celebrities and social media influencers who are willing to shell out big bucks to take advantage of semaglutide’s ability to curb hunger.

Wegovy was on the market for about six months when Novo Nordisk announced it was in short supply, attributing the shortage to an issue with its contracted manufacturer.

After that, many physicians reportedly shifted to off-label Ozempic prescriptions for their patients who needed or wanted to lose weight but could not access Wegovy. This trend intensified under the influence of social media campaigns promoting semaglutide, eventually leading to shortages of Ozempic, as well.

And although Wegovy and Ozempic contain the same active ingredient, Novo Nordisk says they are not interchangeable.

Right now, certain dosage amounts of the two drugs are flagged by the FDA as “in shortage.”  Ozempic was first added to the FDA’s list in August due to a “demand increase for the drug” that could result in localized short-term stock outages in pharmacies that will continue through November.

The drug costs around $900, however since it is not approved for weight loss, Ozempic may not be covered for an individual without diabetes.

In March, Wegovy, which costs about $1,350 for a month’s supply, was included on the FDA’s drug shortages database because of “requirements related to complying with good manufacturing practices.”

Throughout 2022, Novo Nordisk has posted substantial growth in its global diabetes care sales and obesity care sales. According to its most recent financial results reported in August, during the first six months of the year, global diabetes care sales increased 16%, mainly driven by a 45% increase for its GLP-1 (glucagon-like peptide 1) portfolio, a segment that includes Ozempic, Rybelsus and Victoza.

The boost has helped Novo Nordisk capture over 30% of the global diabetes market. Within North America, Novo Nordisk is the market leader, with a nearly 53% value market share compared to 50% a year ago.

According to Novo Nordisk, the growth is due, in part, to increased prescription volume of the GLP-1 class of more than 35% in the first quarter of the year, the company reported. During the first half of 2022, weekly-new-to-brand scripts for Ozempic increased from 20,000 to 28,000 in the U.S.

“There are multiple factors contributing to the supply disruptions of Ozempic, including greater than expected overall demand for Ozempic,” Schneider said. “While we recognize that some health care providers may be prescribing Ozempic for patients whose goal is to lose weight, it is up to the clinical discretion of each health care provider to choose the best treatment approach for their patients. We trust that health care providers are evaluating a patient’s individual needs and determining which medicine is right for that particular patient. Novo Nordisk does not promote, suggest, or encourage off-label use of our medicines and is committed to fully complying with all applicable U.S. laws and regulations in the promotion of our products.”

After reporting an 84% increase in obesity care sales (102% in North American operations and 60% in international operations), the company told investors during an Aug. 3 earnings call that it is continuing to address the previously announced supply issues related to Wegovy.

“Our focus remains to ensure continuity of care in the patients that have already initiated treatment,” said Doug Langa, executive vice president and head of North American operations. “In line with expectations, this has negatively impacted Wegovy prescription trends.”

He added that, “Regarding Wegovy supply, commercial production at the CMO [contract manufacturing organization] was reinitiated in the second quarter of 2022 and inventory building is ongoing. We expect to make all doses of Wegovy available in the U.S. toward the end of the year.”

According to the company, its top priority remains supporting “current patients who have started treatment with Wegovy” and making sure they can advance through the dose escalation and stay on the maintenance dose.

As part of that commitment, Novo Nordisk said it has:

• Asked health care providers to notstart new patients on Wegovy
• Paused advertising and promotions of the drug
• Temporarily stopped shipments of the first two dose strengths (0.25 mg and 0.5 mg)

In addition to restarting commercial production at the contract manufacturing site and conducting ongoing inventory building, Novo Nordisk is making plans for additional production capacity to come on-line in 2023.

With the drugs now in short supply, there are concerns over how it will impact diabetics who need to get their prescriptions filled.

Dr. Robert Gabbay, chief scientific and medical officer at the American Diabetes Association, said the organization “feels strongly that people that have a medical condition should have access to treatment” and is “very much concerned about anything that limits access to effective treatments for diabetes.”

Ozempic “has been an important tool for people with diabetes,” he said. “Not only does it lower blood glucose and weight but it has been shown to decrease cardiovascular events (heart attacks) one of the leading causes of death for those living with diabetes. If they do not have access to the drug, their blood glucose increases, and this turns out over time to a greater risk for complications of diabetes.”

Gabbay went on to say that, in general, when an individual takes a drug off label, the safety and efficacy of the medication may not be the same.

“Drugs go through a rigorous evaluation by the FDA for approval for a particular group of people to know it is safe and effective,” he said.