ATryn(R) Gets CHMP Recommendation To Grant Market Authorization; Indicated For Prophylactic Treatment Of Hereditary Antithrombin Deficient Patients Undergoing Surgery>GTCB
Jun 2, 2006 07:40:00 (ET)
DOW JONES NEWSWIRES
GTC Biotherapeutics Inc.'s (GTCB) treatment for hereditary antithrombin-deficient patients undergoing surgery received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.
GTC said Friday the committee recommended market authorization for ATryn, which may be given in association with heparin or low molecular weight heparin.
The Framingham, Mass., company expects final market authorization by the European Commission in about three months.
The biomedical concern also said ATryn is in a Phase III study of the hereditary deficiency indication as the company prepares a Biologics License Application with the Food and Drug Administration.