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12:00 AM
Jun 12, 2006
 |  BioCentury  |  Product Development

GTC's winning appeal

Although the adage "you can't fight City Hall" applies especially to drug regulators, GTC Biotherapeutics Inc. has managed to convince European reviewers to reverse their February recommendation against approval of the company's ATryn antithrombin alfa.

GTCB (Framingham, Mass.) is seeking a label for ATryn to prevent deep vein thrombosis and thromboembolism in patients with congenital antithrombin deficiency during surgery. If final approval is granted in about three months, it would be the first recombinant protein therapeutic manufactured using transgenic animals.

In its appeal, GTCB persuaded EMEA's CHMP to include data that the agency originally had excluded.

CHMP originally had three issues, according to company spokesperson Thomas...

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