Tag Archive for: stroke

On Friday the agency approved a label expansion for Wegovy based on a supplemental New Drug Application for the indication of reducing risks of major adverse cardiovascular events including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease.

The EU’s drug regulator was still reviewing on Friday whether Novo Nordisk’s popular weight-loss drug Wegovy could also be used in some cases to reduce the risk of strokes and heart attacks.

When given at potentially therapeutic doses, Verve’s base editor led to strong reductions in LDL cholesterol and PCSK9 levels in patients with heterozygous familial hypercholesterolemia.

Under the ORION-17 trial, planned to involve 40,000 patients, Novartis was trying to show that its Leqvio drug could prevent the first occurrence of major cardiovascular health problems in high-cholesterol patients, part of a broader collaboration with the British health system.

Last week the FDA and CDC flagged a potential link between the Pfizer/BioNTech coronavirus vaccine and stroke in older adults; today Israel’s coronavirus task force said it reviewed all its data and did not find an issue.

“EMA can confirm that to date no such signal has been identified in the EU. EMA will continue to evaluate all available data to determine whether emerging safety information could point to a similar signal in the EU,” the agency stated.