You are here

FDA Grants Priority Review on Recombinant Form of Human Antithrombin

FRAMINGHAM, Mass.--(BUSINESS WIRE)--The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB) Biologic License Application, or BLA, for ATryn. Priority Review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009.

“We are pleased that the FDA has recognized the inherent advantage of ATryn as the only recombinant antithrombin product that may become available to patients with hereditary antithrombin deficiency who are at risk of developing serious or potentially life-threatening venous thromboembolic events,” stated Geoffrey F. Cox, PhD, GTC’s Chairman and CEO. “We look forward to continuing our collaborative efforts with the FDA during the review process.”

The FDA’s goal for completing review of applications assigned Priority Review is six months from receipt of the complete application. GTC filed the last section of the BLA on August 7, 2008.

ATryn is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The BLA seeks a license to sell ATryn in the United States for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this rare patient population. GTC has licensed ATryn to OVATION Pharmaceuticals, Inc. to develop and market it in the United States.

Source: GTC Biotherapeutics

Recent Headlines

Scenesse is new treatment for people with rare, painful light sensitivity disease
Humira, Rituxan top list of drugs that added $5.1 billion to nation's health care bill
Lower court rulings cleared the way for generic versions of the MS drug
Maryland man wins lawsuit that alleges that the company's antipsychotic caused his gynecomastia
Antidepressants, ADHD meds are also used to self-poison
Descovy joins Truvada, another Gilead product, in the HIV prophylaxis market
Data show PTC Therapeutics drug preserves lung function
U.S. maintains measles elimination status as NY outbreak ebbs
Study lists steps that could save close to $300 billion a year