New Fabry panel dates

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review on Jan. 13 and 14 BLA's for Fabry disease compounds from Genzyme (GENZ) and Transkaryotic (TKTX). The committee will review GENZ's Fabrazyme agalsidase beta on Jan. 13 and TKTX's Replagal agalsidase alfa on Jan. 14. Last month, the FDA postponed a Sept. 26-27 meeting of the committee slated to review the BLAs after TKTX raised concerns about conflicts of interest among experts FDA had invited to participate in the meeting. TKTX recently said that it had "agreed to disagree" with the FDA over the utility of data on the primary endpoint of its pivotal trial for Replagal (see BioCentury, Oct. 7, 2002). ...