Genzyme/TKT Fabry Agents Receive Co-Exclusive Orphan Drug Status In EU
Executive Summary
Genzyme's Fabrazyme and Transkaryotic Therapies' Replagal will split the 5,000-patient Fabry's disease market in Europe following the awarding of co-exclusive orphan status by the European Commission.
You may also be interested in...
Replagal Advisory Committee Will Include Closed Door Session On Manufacturing
FDA’s Cardiovascular and Renal Drugs Advisory Committee will assess Shire biologics’ BLA for the Fabry disease therapy, which already is available in the U.S. due to shortages of competitor Fabrazyme, during a March 27 meeting.
TKT Replagal Approval Path Will Begin With Request For Protocol Assessment
Transkaryotic Therapies hopes to begin discussion on a potential approval pathway for the Fabry disease agent Replagal in November via a request for an FDA special protocol assessment, CEO Michael Astrue said during an Oct. 29 conference call
TKT Replagal Approval Path Will Begin With Request For Protocol Assessment
Transkaryotic Therapies hopes to begin discussion on a potential approval pathway for the Fabry disease agent Replagal in November via a request for an FDA special protocol assessment, CEO Michael Astrue said during an Oct. 29 conference call