LONDON (Alliance News) - FTSE 100-listed Irish pharmaceutical giant Shire PLC said on Monday it gained a positive opinion from EU's Committee for Medicinal Products for Human Use over the compound Veyvondi.
Veyvondi is used for the treatment of bleeding events and the prevention of surgical bleeding in adults with von Willebrand disease. The submission by the CHMP was based on outcomes from three clinical trials with the disease exposed to Veyvondi.
Von Willebrand disease is an inherited bleeding disorder caused by a deficiency or dysfunction of VMF, one of the proteins in the blood needed for proper blood clotting.
The positive opinion will be reviewed by the European Commission, which has the power to grant marketing authorisation in the EU.
"This positive opinion moves us one step closer to bringing the first, targeted recombinant therapy to people living with von Willebrand disease who still have unmet medical needs. As we continue our long-standing commitment to address unmet needs for people with bleeding disorders, we welcome the potential for individualized treatment of patients with VWD in need of replacement therapy," said Chief Scientific Officer Andreas Busch.
Shares in Shire were down 0.8% at 4,230.50 pence on Monday.
