The European Union’s drug regulator will this week consider wider use of Novo Nordisk’s weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.
Approval could help the Danish drugmaker better argue its case for making the drug available via public sector health systems in Europe.
The possible new use of Wegovy, based on a drug trial known as SELECT, will be assessed during the monthly meeting of a drug assessment panel of the European Medicines Agency (EMA), according to the meeting’s agenda posted on the watchdog’s website on Monday.
Ballooning demand for Wegovy, and for diabetes drug Ozempic which is based on the same active ingredient, has led to a doubling of Novo’s share price over the past two years but it has also overwhelmed the company’s ability to ramp up production of the weekly injections.
For now, people willing to pay for the drugs out of their own pockets have been a major driver of sales growth but public-sector insurers and health systems could underpin the longer-term momentum, analysts have said.
Many European countries have kept a restrictive stance when it comes to health system coverage of drugs that are primarily for weight loss with some, including Germany, even ruling out such payments by law.
The SELECT trial results, published last year, showed that the lower cardiovascular risk ascribed to Wegovy began to appear almost immediately after the obese trial participants starting treatment.
Wegovy had previously been shown to help obese patients lose an average of 15% of their weight, while the SELECT trial separately showed that the drug can reduce the incidence of heart attacks, strokes or death from heart disease by 20%.
Novo submitted applications to both European Union and U.S. authorities last year for a label expansion for Wegovy after the trial data.
Drug regulators can update the information on medicine labels to include new data or reflect new indications for use after initial approval.
EMA typically issues its recommendations on a Friday during the week of its monthly drug assessment meetings. The European Commission has the final word on drug approvals and it typically follows EMA’s endorsements.
Some leading U.S. obesity specialists have said they expect rival Eli Lilly’s new weight-loss drug Zepbound, also known as Mounjaro, to produce the same or similar heart benefits because it has a similar mode of action.
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