Feb 22, 2024
EU Regulator Set to Decide on Wegovy’s Heart Benefits in April
, Bloomberg News
(Bloomberg) -- The European Medicines Agency expects to decide in April whether Novo Nordisk A/S’s weight-loss drug Wegovy can also be used to treat heart patients with obesity, said Executive Director Emer Cooke.
The drugmaker is seeking approval in both Europe and the US for a label change that would allow Wegovy to be prescribed as a therapy to reduce heart attacks and strokes in people who are overweight. The US Food and Drug Administration has granted priority review for Novo’s request.
Novo Nordisk said last August that Wegovy cut the risk of major cardiovascular events by 20% in people who were overweight and had a history of heart disease. Favorable rulings from the regulators designating the drug a heart treatment could make insurers and governments more willing to pay for the drug.
The EMA is also working with the Danish company and international regulators on ways to increase the supply of the blockbuster obesity drugs and manage the growing demand, Cooke said in an interview. “We have a joint meeting with Novo Nordisk and the FDA in early March to see if there is anything else that we can collectively come up with,” she said.
Novo Nordisk is among drugmakers looking to dominate a weight-loss market that’s expected to reach $100 billion by 2035. Demand for the obesity shots has soared, often outpacing what the firm can supply.
The company is already taking a number of measures to increase output, said Cooke. She referred to the use of multidose pens for Wegovy for weight management and Ozempic for the treatment of type 2 diabetes, and the recently announced expansion of its site in France. Novo Nordisk also agreed to buy three of Catalent Inc.’s manufacturing plants.
“The problem at the moment is we don’t have enough supply to meet all the demands of diabetes patients and the obesity patients,” Cooke said. “And then we have additional demand coming from social media celebrity stories, which also inflate the demand for a product that’s short in supply.”
--With assistance from Madison Muller.
©2024 Bloomberg L.P.
