The Food and Drug Administration (FDA) voted not to approve the new blood thinner Eliquis (apixaban), surprising researchers and analysts alike. Eliquis, made by Squibb and Pfizer, was designed to go head-to-head with warfarin, an anticoagulant used to prevent strokes in patients with a heart rhythm problem known as atrial fibrillation. The drug was viewed as a potential blockbuster, a title given to medications that bring in more than $1 billion in one year.

The FDA first delayed its decision on Eliquis in February. Now, drug regulators want the makers of Eliquis to provide more information on how data from a large study that compared Eliquis to warfarin was managed. The agency’s refusal to approve Eliquis surprised both cardiologists and analysts, who were eying the drug as the safest in a new class of medications to prevent strokes in patients with atrial fibrillation.

Warfarin was approved more than 50 years ago for atrial fibrillation patients, but the drug can cause dangerous side effects such as internal bleeding. In 2010, the FDA approved Pradaxa, made by Boehringer Ingelheim, the first in the new class of anticlotting drugs to prevent strokes in atrial fibrillation patients.

In 2011, the FDA approved Xarelto, made by Bayer and Johnson & Johnson, as the second drug in the class with the same indication. The new class promised to be a safer alternative to warfarin, but hope quickly faded when reports of bleeding events and deaths began pouring in to the FDA.

According to the Institute for Safe Medication Practices, an estimated 542 reports of death with Pradaxa were reported to the FDA in 2011. Warfarin, in comparison, was associated with only 72 deaths that same year. Data for Xarelto was not available since the drug has only been available for a few months. Eliquis studies made public last year show that Eliquis prevented more strokes with less bleeding that warfarin.

While the FDA’s rejection of Eliquis was unexpected, Squibb and Pfizer hope to provide more data for the FDA and ultimately get approval for the drug.

Source: NY Times

Related posts:

1. Pradaxa safety issues cause delay in new blood thinner approval
2. FDA rejects Xarelto’s bid to treat acute coronary syndrome
3. Cardiology group compares safety of blood thinners
4. FDA panel rejects expanding indication for blood thinner Xalerto
5. Drug company enjoys rising profits from controversial blood thinner Pradaxa