This week, the European Union’s drug regulatory body is set to review a proposal for extending the usage of Novo Nordisk’s weight-loss medication, Wegovy. The expanded scope includes assessing its potential in reducing the risk of strokes and heart attacks, as outlined in the SELECT drug trial. Novo Nordisk anticipates that approval for this broader application could bolster its case for incorporating the drug into public sector health programs across Europe.
The monthly meeting of the drug assessment panel at the European Medicines Agency (EMA) will scrutinize data from the SELECT trial to evaluate the efficacy of Wegovy in mitigating cardiovascular risks. The drug, which has experienced surging demand alongside Novo Nordisk’s diabetes medication Ozempic, has driven a significant increase in the company’s stock value over the past two years. However, the surge in demand has also strained production capabilities for the weekly injections.
While individual consumers willing to self-fund the medication have contributed substantially to sales growth, the potential inclusion of Wegovy in public-sector insurance and health systems could be pivotal for long-term market momentum. Some European countries, including Germany, have historically been cautious in providing health system coverage for weight-loss drugs, and this review could influence policy considerations.
Results from the SELECT trial, disclosed last year, demonstrated that Wegovy exhibited a rapid reduction in cardiovascular risk among obese participants shortly after initiating treatment. The drug had previously shown efficacy in assisting obese patients in shedding an average of 15% of their body weight. The SELECT trial separately revealed a 20% reduction in the incidence of heart attacks, strokes, or death from heart disease associated with Wegovy.
Novo Nordisk submitted applications for label expansion for Wegovy to both European Union and U.S. regulatory authorities last year, citing the trial’s findings. Regulatory bodies can update medicine labels to include new data or reflect additional indications after initial approval.
The European Medicines Agency typically issues recommendations during the week of its monthly drug assessment meetings, with the European Commission having the final authority on drug approvals, generally aligning with the EMA’s endorsements. Meanwhile, analysts suggest that Eli Lilly’s new weight-loss drug, Zepbound (Mounjaro), could yield similar cardiovascular benefits, presenting potential competition in the obesity treatment landscape.
