Daiichi Sankyo Gains First Approval For Oral Factor Xa Inhibitor In Japan
This article was originally published in The Pink Sheet Daily
Boehringer Ingelheim's Pradaxa has set the bar by showing superiority to standard-of-care warfarin, and Daiichi Sankyo has staked a lot on an ongoing Phase III comparison study of Lixiana (edoxaban) to warfarin for the prevention of thromboembolism in atrial fibrillation, expected to report in 2012.
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FDA’s decision to approve the 150 mg strength of Boehringer Ingelheim GmbH’s antithrombotic Pradaxa (dabigatran), but not the 110 mg dose, reflects agency doubts about the ability of risk management tools to change prescriber behavior that is likely to result in inappropriate use of a less effective dose.
Approval Highs And Lows For Leading Japanese Pharma; Dogged By Competitors And Nagging Supply Issues
TOKYO - Japanese pharma Eisai, Daiichi Sankyo and Mitsubishi Tanabe have had a rough seven days despite last week's slate of new drug approvals in Japan. Those approvals were capped with Mitsubishi Tanabe recalls and Eisai's discontinuation of a key Phase III trial
TOKYO - Daiichi Sankyo's R&D leaders are optimistic about how factor Xa inhibitor edoxaban can compete in a potentially crowded market, but the company is also shifting its focus to development of first-in-class compounds, citing commercial and regulatory hurdles for follow-on, best-in-class products