ThromboGenics/BioInvent's long-acting anticoagulant TB-402 bests enoxaparin in Phase II
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Patients undergoing knee replacement surgery who were injected with TB-402 after surgery had a statistically significant reduction in venous thromboembolism compared to standard-of-care enoxaparin (Sanofi-Aventis' Lovenox) in a Phase II study, co-developers ThromboGenics and BioInvent reported July 9 at the International Congress on Thrombosis in Milan, Italy. TB-402 is a novel recombinant human antibody that partially inhibits Factor VIII, a component of the coagulation cascade. All 316 patients in the study received enoxaparin pre-operatively and then were randomized to receive one of three doses of TB-402, administered as a single intravenous bolus injection 18-24 hours after surgery, or enoxaparin as a subcutaneous injection every day for at least 10 days. Pooled data for the TB-402 arms showed 47 out of 218 pateints (22 percent) experienced VTE compared with 30 out of 77 patients (39 percent) on enoxaparin by days 7-11. The two anticoagulants had similar safety profiles
You may also be interested in...
Zydus Cadila Testing Three-Dose COVID-19 Vaccine
Zydus Cadila is to begin testing a three-dose recombinant DNA vaccine candidate in Phase III Indian trials, which might enter late-stage development ahead of Inovio and AnGes. The company promised to provide 100-150 million doses by end of 2021 at the J.P. Morgan Conference, though adherence could be a roadblock.
Six Questions For Sun Pharma MD Shanghvi
Sun Pharma’s founder and MD shares with Scrip his views on some key big picture issues, including leveraging pandemic-related regulatory experience for urgently needed products, expectations in the US market, the outlook for M&A, and the potential of e-pharmacies in India.
QUOTED. 19 January 2021. Rajiv Nath.
India is allowing importers and manufacturers of certain devices – for whom new licensing requirements came into effect on 1 January – to continue marketing their products for six months if they have already applied for a license. See what Rajiv Nath from the Association of Indian Medical Device Industry (AiMeD) said about it here.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: