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.
Lead Lawyers Appointed in Xarelto Multidistrict Litigation
As Bayer and J&J pursue more studies, plaintiffs continue to file lawsuits against the Big Pharma giants. In December and January, judges in Louisiana and Pennsylvania gathered several cases into multidistrict litigation (MDL) and a mass tort program, respectively.
Collectively, more than 100 lawsuits filed by patients and their families claiming Xarelto caused serious health problems – and death, in some cases – now await trial. The lawsuits also claim that Xarelto’s lack of bleeding antidote makes the drug more dangerous.
The next step in the MDL process is the appointment of a plaintiff’s steering committee.
Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana appointed a 12-member Plaintiffs’ Steering Committee to be headed by Andy Birchfield, Jr. and Brian H. Barr, the co-lead counsels on the cases. Birchfield is from Beasley Allen in Montgomery, Alabama, Barr from Levin, Papantonio in Pensacola, Florida. Also on the steering committee:
- Ellen Relkin, Weitz & Luxenberg, New York
- Bradley Honnald, Bartimus Frickleton, Kansas City
- Frederick Longer, Levi, Fishbein, Sedran & Berman, Philadelphia
- Russell Abney, Ferrer, Poirot & Wansbrough, Atlanta
- Dianne Nast, Nast Law, Philadelphia
- Roger Denton, Schlicter, Bogard & Denton, St. Louis
- Sindhu Daniel, SeegerWeiss, Newark, New Jersey
- Michael Goetz, Morgan and Morgan, Tampa
- Neil Overholtz, Aylstock, Witkin, Kreis & Overholtz, Pensacola
The steering committee will ensure that litigation of multiple cases moves as swiftly and efficiently as possible, including conducting discovery, exploring settlement options and coordinating trial team selection.
In a hearing last month, Fallon said about 30 percent of U.S.-filed Xarelto civil claims are in an MDL.