According to a new medical study Johnson & Johnson’s blood thinner Xarelto worked as well as standard treatment in preventing the recurrence of blood clots in the lung (known as pulmonary embolism) with half the risk of severe bleeding.
The study sponsored by J&J and partner Bayer AG (BAYN), found that the new blood thinner could replace a more complicated two-drug regimen used to treat patients suffering symptoms of potentially life- threatening blood clots in the lungs.
Xarelto, was approved last year for preventing strokes in patients with irregular heart rhythms.
Venous Thromboembolism (VTE) U.S. Case Numbers
There are roughly 900,000 cases of such lung and leg clots each year in the U.S. Blood clots typically start in the legs (deep vein thrombosis) before moving into the lungs, so the two problems are part of the same disease profile.
Johnson & Johnson will apply for U.S. approval in the second quarter for treating lung clots, and for deep vein thrombosis. Xarelto competes in the stroke-prevention market with Pradaxa from Boehringer Ingelheim GmbH.
VTE Treatment Options
Standard protocol for VTE in the lung begins with patients on the injected drug enoxaparin and warfarin. Then after 5 to 10 days, patients go off that drug and continue with the warfarin to prevent the condition from recurring. Warfarin is hard to use because regular blood tests are needed to ensure people are getting an appropriate and safe dose.
In the trial, Johnson & Johnson and Leverkusen, Germany- based Bayer tested whether Xarelto could replace both drugs. Patients were randomly assigned to Xarelto or standard therapy. Patients in the Xarelto group took the drug twice a day for the first three weeks, and a slightly higher dose once a day after that for as long as a year.
At the end of the trial, 2.1 percent of patients on Xarelto had experienced new clots in the legs or lungs, including fatal clots, versus 1.8 of those who got standard therapy. These numbers were statistically comparable, according to the findings that are also being published in the New England Journal of Medicine.
Less Severe Effects
When all bleeding episodes were counted, the primary safety measure in the study, the risk of bleeding was similar in the two regimens. Yet only 1.1 percent of patients on Xarelto had severe hemorrhage, versus 2.2 percent of those on standard therapy.
Pradaxa FDA Approval Decision
Pradaxa isn’t approved for lung clot treatments. Boehringer is analyzing the data now and deciding whether to seek approval. Pradaxa is approved in Europe for clot prevention after hip and knee surgery as well as in Europe and the U.S. for stroke prevention in non-valvular atrial fibrillation.
Bristol Myers Squibb Co. and Pfizer Inc. are in final-stage trials of blood thinner Eliquis for treating leg or lung clots. The drug is under U.S. regulatory review for stroke prevention in irregular heart rhythm patients.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.