What's long been a three-horse race just gained a fourth horse with the FDA's green light for Daiichi Sankyo's clot-fighter Savaysa. With the FDA's Thursday blessing, the drug will now face down a new-age anticoagulant trifecta that's been duking it out in the marketplace for a while now.
The Japanese pharma's once-a-day pill, which won the FDA's blessing to reduce stroke in patients with atrial fibrillation and treat deep vein thrombosis and pulmonary embolism, will go up against Johnson & Johnson ($JNJ) and Bayer's Xarelto, which leads the pack of next-gen options as the only other once-daily oral treatment on the market. Following behind it are Boehringer Ingelheim's Pradaxa and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis, the newest of the bunch. And that's not to mention standard therapy warfarin, whose market share all three therapies have been trying to snatch up since their rollouts.
And the way some industry-watchers see it, it could be difficult for Savaysa to elbow its way in. "There is no unique advantage this drug offers relative to existing therapies," Sanjay Kaul, who served on the FDA advisory panel that reviewed the med, told Forbes following approval. "As such, clinical acceptability and marketability will pose a major challenge for this drug."
Pfizer and BMS can certainly speak to the market's hurdles. Analysts expected big things from Eliquis, which in clinical trials reduced major bleeding over warfarin and improved mortality. But to call the therapy's launch sluggish would be an understatement; between October 2012 and October 2013, analysts revised their 2014 Eliquis sales predictions downward by 60%. Only after its makers plowed money into marketing efforts did the treatment start showing signs of life in last year's Q2.
And Xarelto, which nabbed the No. 1 spot from first-to-market Pradaxa and hasn't looked back since, isn't showing any signs of slowing down. J&J and Bayer are knee-deep in clinical trials they hope will help widen the drug's label, with an eye on OKs in embolic stroke of undetermined source, peripheral artery disease and acute coronary syndrome--a nod that's so far eluded the pharma giants after three FDA rejections.
- read the FDA's release
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