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Pharmaceuticals / Submissions and Approvals

Pfizer and BMS's Eliquis Gets FDA Nod for Third Indication

Aug. 29, 2014

Pfizer and Bristol-Myers Squibb’s blood thinner Eliquis won a new indication for the treatment of blood clots deep in the legs and lungs.

The FDA approval was based on a global study of roughly 5,244 patients with confirmed symptomatic deep vein thrombosis and pulmonary embolism who were given either Eliquis (apixaban) or the existing standard of care, Lovenox (enoxaparin) and warfarin.

While Eliquis showed comparable efficacy against recurrent, symptomatic DVT or PE, it proved to be superior to standard of care in reducing incidents of major bleeding in critical areas, including fatal bleeding, Pfizer spokeswoman Jennifer Kokell said.

This is the third indication for the drug, which also is approved to reduce the risk of stroke and blood clots in patients with irregular heart rhythms, and as a preventive treatment of deep vein thrombosis, which may lead to blood clots in the lungs of patients who have undergone hip or knee replacement surgery.

Eliquis comes with a hefty set of boxed warnings. Patients who stop taking the oral therapy early, for example, are at increased risk of blood clotting. Patients who undergo epidural anesthesia or spinal puncture may end up with epidural or spinal hematoma, potentially ending in paralysis. A third warning is for potentially fatal bleeding.

The drug was first approved in 2012. It also has received the latest indication in the European Union, Kokell said. Eliquis garnered $171 million in sales in the second quarter of 2014, according to BMS. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.