FDA refuses to expand lepirudin use
FDA refuses to expand lepirudin use
Fri, 19 May 2000 16:48:34
Parsippany, NJ - The FDA refused to expand the use of the anticoagulant lepirudin (Refludan®) to prevent CVD and new MI in patients suffering from acute coronary syndromes (ACS), the regulatory agency said in a non-approval letter to Aventis Pharmaceuticals. The letter followed the recommendation of the FDA's Cardio-Renal Drugs Advisory Committee earlier this month. The committee members voiced concern about the drug's safety because of instances of excess bleeding and stroke in ACS treatment, heartwire reported.
Another direct thrombin inhibitor, bivalirudin (Angiomax? - The Medicines Company), on the other hand, was granted approval by the FDA on May 17 for treatment of unstable angina in PTCA, as reported by heartwire.
Lepirudin will remain on the market for treatment of heparin-induced thrombocytopenia (HIT) type 2 and associated thromboembolic disease, Aventis said. The drug is approved in 32 countries for HIT treatment.
Parsippany, NJ - The FDA refused to expand the use of the anticoagulant lepirudin (Refludan®) to prevent CVD and new MI in patients suffering from acute coronary syndromes (ACS), the regulatory agency said in a non-approval letter to Aventis Pharmaceuticals. The letter followed the recommendation of the FDA's Cardio-Renal Drugs Advisory Committee earlier this month. The committee members voiced concern about the drug's safety because of instances of excess bleeding and stroke in ACS treatment, heartwire reported.
Another direct thrombin inhibitor, bivalirudin (Angiomax? - The Medicines Company), on the other hand, was granted approval by the FDA on May 17 for treatment of unstable angina in PTCA, as reported by heartwire.
Lepirudin will remain on the market for treatment of heparin-induced thrombocytopenia (HIT) type 2 and associated thromboembolic disease, Aventis said. The drug is approved in 32 countries for HIT treatment.
|