P.D. P.J. : En la FDA Calendar han actualizado los Farmacos que van a ser evaluados hasta el 13 de Mayo ... y de momento aún no aparece Yondelis .
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Posted February 17th, 2015 by Michelle Llamas & filed under Current Litigation & Lawsuit News.
Bayer and Johnson & Johnson announced late last month they will push for additional Food and Drug Administration (FDA) approvals for the blockbuster blood-thinner Xarelto, even as two U.S. courts consolidated bleeding lawsuits against both companies.
Part of a class of new anticoagulants called Factor Xa inhibitors, the drug officially overtook its classmates and captured the largest share of the market thanks to its array of approved uses.
The popular blood thinner pulled in $1.5 billion in sales last year, and now, the drug’s makers want to pursue approvals for stroke patients, according to Fierce Pharma Marketing. The medication is facing off against a mainstay of stroke prevention: aspirin.
The latest push for additional federal approval comes amid concerns over a lack of antidote to stop potentially fatal bleeds and an increased number of lawsuits state and federal courts.
A new 7,000-patient trial — called the NAVIGATE-ESUS study — will focus on the effectiveness of Xarelto vs. aspirin in preventing subsequent strokes. Approximately 300,000 people in North America and Europe suffer these strokes annually, potentially broadening Xarelto’s reach, if it gains a wider approval.
Xarelto Could Overtake Warfarin
J&J CEO Alex Gorsky said Xarelto already has as customers one-third of former warfarin users and that the medication may be poised to take the remaining two thirds if it gains extra approvals, according to Fierce Pharma Marketing. The company touts Xarelto as having the lowest out-of-pocket costs for patients of all the new blood thinners.
Gorsky didn’t comment on the recent Xarelto lawsuit consolidations in Louisiana and Philadelphia, where a growing number of plaintiffs say drugmakers failed to warn them that Xarelto increasing the risk of severe bleeding.