Daiichi clot-buster wins a NICE green light, but still faces an uphill track

As the fourth market entrant in a hotly contested group of new-age anticoagulants, Daiichi Sankyo's Lixiana (edoxaban) has some ground to make up. Luckily, it got a boost in the U.K. that could help it build momentum.

NICE's Carole Longson

The country's cost-effectiveness gatekeeper, the National Institute for Health and Care Excellence (NICE), has handed the drug its second nod, 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 hemorrhagic strokes compared with old standby warfarin, and it 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.

But it's not just warfarin that the Japanese pharma 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--had 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."

And on top of being late to the party, the med bears a black-box warning discouraging patients with normal renal function from using Savaysa.

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 bad news for Daiichi, which is bracing for the loss of patent protection on top treatment Benicar.

"The company is in a little bit of a tricky position at the moment," Falcetti told Bloomberg in February. "I can't see an obvious solution to their problem."

- read NICE's release

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