The
Wall Street Journal (1/16,
Subscription Publication, 5.91M) reports Johnson & Johnson and Bayer AG did
not receive the backing of an FDA advisory panel to expand the use of their
blood-thinner Xarelto (rivaroxaban) as a potential therapy for patients with a
certain heart problem The paper says the decision follows a review of the
results of a Phase 3 trial.
Bloomberg News (1/16, Edney, 1.91M)
reports the rejection by the panel raises “another challenge in the companies’
repeated effort to sell the drug to a bigger group of heart patients.” Xarelto
“shouldn’t be approved to help prevent heart attacks and strokes 90 days after
patients experience serious chest pain or cardiac illness, a condition known as
acute coronary syndrome,” according to the panel, which voted 10-0 today with
one abstention. Bloomberg says this the company’s “third attempt to gain FDA
clearance for such patients.”
The
AP (1/17) provides details of
the panel’s argument in rejecting the expanded use of the medication, “saying
too much information is missing from company studies to accurately gauge
Xarelto’s benefit.”
CardioSource (1/17, 2K) points
out that the medication “is FDA-approved to prevent stroke in non-valvular
atrial fibrillation, treat deep vein thrombosis (DVT) and/or pulmonary embolism
(PE) and reduce the risk of recurrence of DVT and PE following initial
treatment, and prevent DVT after knee or hip replacement surgery.” Also
covering the story are Reuters
(1/17), Forbes (1/16, 6.03M), MedPage Today (1/17, 122K), and Medscape (1/17, 164K).
Posted
by: Steven Almany M.D.
No comments:
Post a Comment