Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures.
Novo Nordisk on Monday announced that it expects the shortage for the lower doses of its blockbuster GLP-1 therapy Ozempic (semaglutide) to persist into the fourth quarter of 2024, according to reporting from Reuters.
The supply squeeze is driven by the consistently high demand for the incretin treatment as well insufficient production capabilities, according to Reuters. Intermittently, higher doses of Ozempic may also have limited availability into Q4.
With Monday’s supply update, Novo continues to struggle to keep up with the market’s insatiable appetite for its GLP-1 portfolio. Since the approval of Ozempic’s sister brand Wegovy (semaglutide) in June 2021 for chronic weight management, the Danish drugmaker has been met with overwhelming demand that rapidly outpaced its manufacturing capacity.
Manufacturing problems compounded the problem, with Novo announcing in December 2021 that a third-party fill-finish provider had to stop deliveries due to “issues with Good Manufacturing Practices.”
However, several investments in manufacturing have helped the pharma make substantial progress. Earlier this month, the FDA updated its drug shortages database to show that Novo has cleared most shortages of Ozempic and Wegovy and that only the lowest dose of the weight-loss therapy will have limited availability. The regulator has not specified when it expects the shortage to be resolved.
Novo’s efforts to beef up its production capacity include a $6 billion investment in November 2023, earmarked for its Denmark operations, as well as a $16.5 billion contract in February to acquire CDMO giant Catalent. The pharma also pumped $4.1 billion into its Clayton, North Carolina footprint in June 2024, which will go toward the construction of a 1.4-million-square feet production facility.
Still, Novo continues to push semaglutide into new indications, potentially making its GLP-1 therapies available to more patients—in turn putting more pressure on its supply. Wegovy, for instance, won the FDA’s approval in March 2024 to lower the risk of cardiovascular death, heart attack and stroke in overweight or obese patients with cardiovascular disease.
In line with this effort, Novo on Monday published a pooled analysis using data from the Phase III SELECT, FLOW, STEP-HFpEF and STEP-HFpEF DM studies, demonstrating that semaglutide carries significant cardiovascular benefit. Drawing data from more than 3,000 patients showed that Novo’s GLP-1 receptor agonist cut the risk of combined cardiovascular death or worsening heart failure by 31% relative to placebo.
The findings, published in leading medical journal The Lancet, could help Novo rebuild its case of using semaglutide in heart failure after the drugmaker announced last month that it had pulled its heart failure filing for Wegovy. Novo said it expects to resubmit early next year.
