Was this expected? The FDA has decided to give priority review to the forthcoming Eliquis bloodthinner from Pfizer and Bristol-Myers Squibb, the latest signal that the medication may well dominate the market for treating atrial fibrillation, which occurs in more than 2 million Americans and is a common type of abnormal heart rhythm.
Specifically, the drugmakers are seeking approval to market Eliquis to prevent stroke and systemic embolism in patients with atrial fibrillation, and a decision is due by March 28 (read the Bristol statement here). If approved, Eliquis would join two other new meds - Pradaxa, which is being heavily marketed by Boehringer Ingelheim, and Xarelto, which is marketed by Bayer and Johnson & Johnson, but received a black box warning (see this).
Three months ago, Phase III results for Eliquis were released and showed the bloodthinner prevented more strokes with less major bleeding than warfarin, the decades-old standard treatment in patients with atrial fibrillation, and also reduced the number of deaths. Both Eliquis and Pradaxa are twice-a-day drugs, but Eliquis has stronger safety data and better tolerability. Moreover, Pfizer and Bristol have significant experience marketing cardiovascular drugs (back story).
Nonetheless, why should Eliquis be granted a priority review when the others were already approved? A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, according to the FDA (read here). This suggests, in other words, that the agency views Eliquis as a significant addition to the medical armament.
As ISI Group analyst Marc Schoenebaum points out in an investor note, Xarelto did not receive priority review, but the designation was given to Pradaxa, which was the first 'warfarin replacement' to come before the FDA with potential superiority data. And since Pradaxa was already approved by the time Xarelto was reviewed, there was "no longer an unmet medical need," he writes.
"In addition, the FDA may have viewed the 'superiority' data for Xarelto with suspicion from the very beginning," he adds. In the key Xarelto trial, the efficacy endpoint was measured after patients were crossed back to warfarin near the end of the study, which Bayer and Johnson & Johnson previously argued led to an increase in last-minute strokes that produced less than stellar results. In his view, the priority review designation for Eliquis indicates to us that FDA views the potential superiority...to warfarin on both efficacy and safety as important and potentially real...(Eliquis) is the only new a-fib drug thinner to show superiority on safety (bleeding). This may have been the most important determinant of PR status. We continue to expect that (Eliquis) will carry clear label language for superiority on both safety and efficacy, making it the dominant player in the a-fib market," he concludes.
In her own note, Deutsche Bank analyst Barbara Ryan writes that, "We don't think it was baked into general expectations that an expedited review would be granted, hence the drug likely gets on the market six months earlier than many had expected...Based upon the FDA's designation and the Eliquis data, we believe that the drug will get a superiority claim to warfarin, and the survival data will at a minimum be included in the label." She forecasts global sales of $250 million next year, and peak sales of $2.5 billion.