Daiichi Clot-Buster Wins a NICE Approval, But Still Faces an Uphill Challenge

Daiichi_Sankyo_logoAs the fourth market entrant in a competitive group of new-age anticoagulants, Daiichi Sankyo’s Lixiana (edoxaban) has a long way to go. Luckily, it got a boost in the U.K. that could help it gain momentum.

The country’s cost-effectiveness gatekeeper, the National Institute for Health and Care Excellence (NICE), has given the drug it’s second approval, recommending it to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more other risk factors–such as congestive heart failure, high blood pressure or prior stroke history.

According to NICE Health Technology Evaluation Centre Director Carole Longson, there’s evidence that Lixiana nearly halved the rate of haemorrhagic strokes compared with old standby warfarin, and also doesn’t require the frequent blood testing to monitor treatment that warfarin does. “Taking all the evidence into account, edoxaban is clinically and cost effective compared with warfarin and can be recommended as an alternative,” she said in a statement.

Although warfarin isn’t the only anticoagulant that the Japanese pharma company has to worry about. A trio of competitors–Johnson & Johnson ($JNJ) and Bayer’s Xarelto, Boehringer Ingelheim’s Pradaxa, and Pfizer ($PFE) and Bristol-Myers Squibb’s ($BMY) Eliquis–have already been vying for the lead in the next-gen clot-busting space when Lixiana came along. Called Savaysa in the U.S., edoxaban won FDA approval in January.

“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 the approval. “As such, clinical acceptability and marketability will pose a major challenge for this drug.”

All things considered, Cantor Fitzgerald analyst Emilia Falcetti sees the drug netting $220 million in fiscal 2019–well behind the sales figures that leader Xarelto and No. 2 Pradaxa are already putting up. And that’s another challenge for Daiichi, which is bracing for the loss of patent protection on top treatment Benicar.


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