Boehringer gets NICE nod for Pradaxa for DVT/PE in U.K.


Boehringer Ingelheim has completed a trifecta of approvals for its blood thinner Pradaxa for deep vein thrombosis and pulmonary embolism. The U.K. cost watchdog NICE has now given it a thumbs up after the FDA and the European regulators did the same thing this year.

NICE found the drug was cost effective enough to be recommended for approval for the two indications in acute cases, PharmaTimes reports, falling under its price range of £20,000 ($32,000) per quality-adjusted life-years when compared with the standard treament of warfarin, a drug that comes with additional monitoring costs. It also recommended it for combined treatment and secondary prevention, the publication reported.

Pradaxa was first to market as one of the new blood thinners that are less onerous to take than warfarin, which comes with serious bleeding risks. Pradaxa sales grew 9% to about $1.7 billion last year and is key as the drugmaker fights off revenue declines from other products. The drugmaker in August said it was cutting its workforce by 15% in Germany as H1 pharma revenues fell 5.4%.

But Pradaxa and its competitors have bleeding risks of their own. Pradaxa primarily competes with Eliquis from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY), as well as Xarelto from Johnson & Johnson ($JNJ) and Bayer, which now leads the category in sales. In July, the BMJ scolded Boehringer for allegedly burying data about the need for regular testing for bleeding risk of patients taking the drug and the FDA and European regulators for being slow to follow-up on reports of bleeding.

Unlike warfarin, Pradaxa and the other new anticoagulants don't have antidotes, but Boehringer hopes to soon reach the market with one. In June, the FDA granted breakthrough therapy designation for its in-development antidote, a fully humanized antibody fragment designed to reverse the anticoagulant effects of Pradaxa, which prevents clotting by blocking the enzyme thrombin.

- read the PharmaTimes story

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