Novastan: Better late than never

Despite underestimating the pitfalls of conducting clinical trials with its Novastan argatroban direct thrombin inhibitor, Texas Biotechnology Corp. finally has its approvable letter from the FDA to treat or prevent heparin induced thrombocytopenia (HIT). In hindsight, TXB believes that a better understanding of the clinical trial process was needed from the outset. Specifically, the company did not anticipate how difficult it would be to assemble historical control data for comparison with Novastan.

TXB in-licensed Novastan in 1993 from Genentech Inc. (DNA, South San Francisco, Calif.). The product, which was originally developed by Mitsubishi Chemical Corp. (Tokyo, Japan), had been on the market in Japan since 1991. TXB began its original NDA submission in July 1997, but ran into several delays, including a non-approvable letter in May 1998 and database corrections that were required for its amended NDA submission in March 1999 (see BioCentury, Aug. 30, 1999)...