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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.

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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

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