Nice deal. Thanks
TXBI sNDA approved.
Tuesday April 9, 7:04 am Eastern Time
Press Release
SOURCE: GlaxoSmithKline; Texas Biotechnology Corporation
GlaxoSmithKline and Texas Biotechnology Receive FDA Approval for New Indication of Argatroban
Approval Offers Benefits to Patients With or at Risk for Heparin-Induced Thrombocytopenia (HIT) Undergoing Percutaneous Coronary Interventions (PCI)
HOUSTON, and PHILADELPHIA, April 9 /PRNewswire-FirstCall/ -- Texas Biotechnology Corporation (Nasdaq: TXBI - news) and GlaxoSmithKline (NYSE: GSK - news) announced that the U.S. Food & Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for the new use of Argatroban as an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia (HIT) undergoing percutaneous coronary interventions (PCI).
Argatroban is currently approved for the prophylaxis or treatment of thrombosis in patients with HIT. Argatroban, which was co-developed by Texas Biotechnology and GlaxoSmithKline, is currently marketed in the U.S. by GlaxoSmithKline.
Bruce D. Given, M.D., President and CEO of Texas Biotechnology stated, ``This second approval from the FDA demonstrates both our commitment and our ability to expand the use of Argatroban beyond its initial indication and optimize its use in a number of hospital based cardiovascular indications.'' Dr. Given added, ``Further evidence of our commitment to find new, beneficial uses is reflected in our ongoing Phase II clinical trials with Argatroban in ischemic stroke and in the overall PCI market.''
HIT is an immune-mediated response to heparin that can lead to serious thrombotic complications and death. Heparin, the most widely used anticoagulant, is used in virtually all interventional coronary procedures such as balloon angioplasty or stent implantation. According to the American Heart Association, more than 500,000 interventional procedures are performed annually in the United States and it has been estimated that more than 1 million procedures are performed worldwide. For patients undergoing PCI who have or are at risk of developing HIT, Argatroban meets an unmet medical need as there is currently no FDA approved alternative anticoagulant available.
``We are very pleased to see this additional indication in the Argatroban label. Argatroban saves lives for those patients at risk and who may suffer HIT consequences,'' stated Kevin Lokay, Vice President of Oncology at GlaxoSmithKline. ``This approval is one more step forward in our commitment to improving the awareness and treatment of HIT.''
According to Dr. William Matthai, Clinical Associate Professor of Medicine, University of Pennsylvania Medical School, Division of Cardiology, ``The clinical importance of HIT is now recognized by most physicians, which is further supported now that there is an agent approved for use during angioplasty in patients with or at risk for HIT. Our studies and clinical experience have shown that Argatroban provides effective and safe anticoagulation for these patients.''
A Review of the Efficacy and Safety of Argatroban in HIT Patients
Undergoing PCI
In a combined analysis of three studies, HIT patients treated with
Argatroban who underwent PCI were assessed for adequate anticoagulation and
procedural success according to investigator ratings. Investigators also
rated Argatroban for its impact on reducing acute procedural situations such
as death, emergent bypass surgery or Q-wave myocardial infarction. Acute
procedural success and major bleeding rates were compared with historical data
obtained from the Cleveland Clinic Registry and the heparin arm of the EPILOG
trial, respectively. Results from the trials indicate that of the 91 patients
treated with Argatroban, 98% had adequate anticoagulation, and acute
procedural success was achieved in 98% of Argatroban-treated patients versus
94% in the control group. No death or Q-wave myocardial infarction occurred.
Similarly, major bleeding rates for Argatroban patients compared favorably
with historical controls (1.8% versus 3.1%, respectively). Major bleeding
events, which occurred in 2 patients, were retroperitoneal and
gastrointestinal. |
