Novo Nordisk weight-management treatment hits supply snag

20-Dec-2021 - Last updated on 20-Dec-2021 at 16:32 GMT

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The pharmaceutical company has announced GMP-related challenges with a manufacturer contracted to fill syringes for Wegovy pens headed to the US market.

Novo Nordisk has announced that a contract manufacturer, who had been tasked with filling syringes for injection pens intended to dose patients with its Wegovy (semaglutide) weight-management treatment—has temporarily stopped manufacturing and deliveries. According to Novo Nordisk, the stoppage is associated with unspecified challenges related to meeting Good Manufacturing Practices (GMP) standards.

As a result, Novo Nordisk leadership stated, its leadership does not anticipate it will be able to meet the demand from the US market for the first half of 2022. Further, the pharmaceutical company does not expect that any significant number of new Wegovy patients will be able to begin their treatment with the drug.

For the time being, the company announced it is placing priority on delivery to patients who have already kicked off their treatment regimen with Wegovy. Executives added that they expect to be able to meet the demand for the drug in the second half of next year.

In July 2021, the US Food and Drug Administration granted its approval to Wegovy, which is a once-a-week injectable treatment. It is indicated for chronic weight management in adults who are obese or overweight, and who also have at least one weight-associated condition, such as high blood pressure, type 2 diabetes, or elevated cholesterol.

Excess weight is an issue in much of the world, but of particular concern in the US. According to figures from the FDA, about 70% of adults living in the US have obesity and or overweight.

“Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favor weight regain,” said Martin Holst Lange, executive vice president of development at Novo Nordisk, at the time of Wegovy’s FDA approval. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy available to people living with obesity in the US.”