The FDA will consider Eliquis for a new indication, one which Pfizer ($PFE) and partner Bristol-Myers Squibb ($BMY) hope can help the blood thinner hit the sales potential analysts predicted for the drug before it was approved.
The companies said today that the FDA will review the drug for prevention of deep vein thrombosis (DVT) in adult patients who have had hip or knee replacement surgery. They said the goal date for a decision is March 15, 2014. The submission is backed by their three ADVANCE clinical trials, which are part of the EXPANSE clinical trial program.
In late December, the FDA approved Eliquis for reducing risk of stroke and blood clots in patients with non-valvular atrial fibrillation. The agency said it shouldn't be used in patients with artificial heart valves or defective heart valves.
While Eliquis has been on the market only about 6 months, a Pfizer exec recently acknowledged that it had not hit the market with the momentum the company had hoped. Estimates initially put peak sales around $5 billion. Analysts have revised their sales forecasts for the drug, predicting slower growth, with 2016 sales amounting to about $615 million. There had been big expectations before its approval that it might quickly steal market share from its previously approved competitors, Boehringer Ingelheim's Pradaxa and Johnson & Johnson ($JNJ) and Bayer's Xarelto. Pfizer has said that because those drugs got to market earlier, it can be difficult to get doctors to switch their patients.
Earlier this month, the companies also reported that the anticoagulant hit its primary goal in its AMPLIFY study. It matched standard treatment for potentially life-threatening blood clots, efficacy-wise. And it beat warfarin on the safety side, with a 69% reduction in the risk of major bleeding. Those results support Eliquis for treating deep vein thrombosis (DVT) and pulmonary embolism (PE). That group of patients amounts to about 1 million patients per year in Europe and 900,000 in the U.S.
Today's news might also distract attention from reports that approval of the drug by the FDA was held up as it looked into alleged fraud at clinical trial sites in China.
- here's the release