|To:||File , BLA, STN 125284/0 , Antithrombin alfa|
GTC Biotherapeutics , Inc. (License # 1794)
|From:||Chiang Syin, Ph.D., Chief, CBER/OCBQ/DMPQ/MRB II, HFM-676|
|Subject:||Categorical exclusion under 21 CFR § 25.31(c)|
|Through:||Laurie P. Norwood , M.S., Deputy Director, CBER/OCBQ/DMPQ|
I have reviewed pertinent sections of the Biologics License Application (BLA) (STN BL 125284/0 ) from GTC Biotherapeutics, Inc. (GTC) submitted for the manufacture of Antithrombin alfa for restoration of human plasma antithrombin levels to normal in patients diagnosed with congenital antithrombin deficiency. For patients with this condition, treatment is typically administered only once or a few times in a patient's life with treatment usually occurring over a period of several days. I find that the request for a categorical exclusion from an environmental assessment under 21 CFR 25.31(c) is justified because this product falls into the category of substances that occur naturally in the environment and the action (approval of the BLA) would not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.
In addition, FDA's Center For Veterinary Medicine (CVM) (based on information submitted by GTC) has prepared an Environmental Assessment (EA), pursuant to 21 CFR 25.20(m) and 21 CFR 25.40, concerning GTC's new animal drug application (NADA) for the rDNA construct that directs the expression of human antithrombin III (ATryn) in the milk of lactating does (goats). CVM has issued a finding of no significant impact, 21 CFR 25.41, stating that the approval of GTC's NADA will not significantly affect the human environment.
Date Chiang Syin, Ph.D., HFM-676
Date Laurie P. Norwood, M.S.
Division of Manufacturing and Product Quality