Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Pharamceuticals’ drug Xarelto, an anticoagulant that has produced positive phase 3 results to treat clots in the lung in a recent study, could set the standard for a new generation of anticoagulant drugs.
In the study of 4,833 patients, Xarelto was demonstrated to be comparable to patients taking warfarin and heparin. The report was published in the New England Journal of Medicine this week.
Patients on warfarin need to be monitored more closely than those on Xarelto because if their blood levels rise above the international normalized ratio, or INR, it indicates a high risk of bleeding and if it falls below the INR, it means there’s not enough warfarin to prevent blood clots from developing. It also interacts with several other medications and chemicals in some foods.
Pulmonary embolisms are one of the most common causes of death in a hospital. For every 100,000 people there are 70 cases. Hospitalization is required and there’s a potential for recurrence.
Xarelto, developed with Bayer, along with other anticoagulants being developed by Bristol-Myers Squibb and Pfizer, and Boehringer-Ingelheim represent a shift in how pulmonary embolisms have been treated for decades, according to the study.
Frank Misselwitz, head of Bayer’s cardiovascular unit, told Bloomberg Business Week that preventing pulmonary embolism is the “ultimate proof of the pudding,” for a blood thinner. “It’s the litmus test. We have a large clot existing; it’s potentially life threatening. You’re not just preventing a clot but treating it in the initial phase.”
New Jersey-based Janssen plans to file the research results in a supplemental new drug application for Xarelto with the U.S. Food and Drug Administration in the second quarter.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Analysts estimate the additional applications for Xarelto could add $600 million for the drug on top of the estimated peak sales of up to $4.2 billion it is expected to garner as a stroke prevention remedy in adults with an irregular heartbeat for which it was approved by the FDA last year. It also prevents blood clots in people recovering from hip or knee replacement surgery.
Other companies are also developing new generations of anticoagulants. Eliquis from Bristol-Myers Squibb and Pfizer is being developed to prevent strokes in patients with atrial fibrillation. It has been approved to prevent clots in people who have recently undergone hip and knee replacement surgery in Europe, but is not approved to treat lung clots. Although Boehringer-Ingelheim’s Pradaxa is approved in the U.S. to prevent clots in people with atrial fibrillation, the makers are reviewing whether to seek approval for the drug to prevent clots in the lung.
