Company news: Boehringer Ingelheim

Share this article:
An FDA advisory panel yesterday unanimously recommended that the agency approve anticoagulant Pradaxa (dabigatran) to reduce the risk of stroke and blood clots in patients with atrial fibrillation. The recommendation put sponsor Boehringer Ingelheim on course to secure possible marketing clearance later this year—an FDA action date is slated for Oct. 19—giving the firm pole position in the race to bring a new kind of stroke drug to the US market and replace warfarin, a drug which has been used for decades but which requires expensive monitoring. Several other firms have blood thinners in testing for the same indication. Johnson & Johnson and Bayer expect to file rivaroxaban, sold abroad as Xarelto, later this year and are due to present data from an important trial in November at the American Heart Association meeting. Bristol-Myers Squibb and Pfizer are co-developing apixaban, while Merck and Portola plan to start a Phase III trial of betrixaban in atrial fibrillation next year. Daiichi Sankyo is also studying edoxaban.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.