The European Medicines Agency (EMA) is reviewing a request to expand the use of a diabetes and obesity drug for cardiovascular problems that is already approved in the United States.
“The EMA Committee for Medicinal Products for Human Use is currently considering a request to extend the indications for Wegovy. [não comercializado em Portugal] and we cannot speculate when it will be completed,” an agency source told Luse this Monday.
The same source added that the EMA’s assessments are independent from those of its North American counterpart, the FDA.
The FDA approved the anti-obesity drug Wegovy on Friday to reduce the risk of stroke, heart attack and other cardiovascular problems in obese or overweight people.
The active substance of the drug is semaglutide, present in another drug, Ozempic, approved and reimbursed in Portugal for the treatment of type 2 diabetes and which was sold out at the end of 2023 due to its prescription for weight loss.
The U.S. approved a label change for Wegovy proposed by Danish pharmaceutical company Novo Nordisk, expanding the use of semaglutide.
The pharmaceutical company submitted a similar request to the EMA.
Author: Lusa
Source: CM Jornal
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