Bayer, J&J Suffer FDA Setback

By Zvi Bar:On Thursday, advisers to the U.S. Food and Drug Administration voted to recommend approving a new anti-clotting drug, Xarelto, for uses that would broaden its application to millions more patients. The 12-member panel voted 9-2 to recommend approving Xarelto to prevent strokes in patients with atrial fibrillation, an irregular heart rhythm, with one member abstaining.

The Food and Drug Administration has approved Xarelto, the new blood thinner from Johnson & Johnson and Bayer. The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto rivaroxaban to reduce the risk of stroke in people who have abnormal heart rhythm non-valvular atrial fibrillation.Atrial fibrillation occurs in more than 2 million Americans ...

[AP] - A negative review from Food and Drug Administration staff bodes ill for a new blood thinner from Johnson & Johnson. An FDA staff report released Tuesday recommends against approving Xarelto for preventing strokes in patients with a common irregular heart rhythm called atrial fibrillation.

[AP] - A negative review from Food and Drug Administration staff bodes ill for a new blood thinner from Johnson & Johnson. An FDA staff report released Tuesday recommends against approving Xarelto for preventing strokes in patients with a common irregular heart rhythm called atrial fibrillation.

By Smith On Stocks:The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s (JNJ) Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time).

By Pharmalot: If numbers tell a story, then Bayer (BAYN.PK) and Johnson & Johnson (JNJ) may have some explaining to do.

Pharmalot submits: There has been a great deal of chatter and speculation over the widely anticipated results of a clinical trial of Xarelto, a forthcoming bloodthinner being developed by Bayer (BAYRY.PK), which has a partnership deal with Johnson & Johnson (JNJ).

The Burrill Report submits: Merck (MRK) said it was discontinuing a study of its experimental anticlotting drug vorapaxar in patients with acute coronary syndrome after a data safety monitoring board reviewed safety and efficacy data and recommended the study be halted.