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Pradaxa, Xarelto and apixaban vie for attention

Published on 06/09/10 at 09:53am

New data has intensified the competition between three rival would-be cardiology blockbusters.

Boehringer Ingelheim’s Pradaxa (dabigatran) and Bayer’s Xarelto (rivaroxaban) are both approved as anti-blood clotting treatments in Europe, but have yet to gain the all-important approval from the US.

Now Pfizer and BMS’s apixiban is also close to being filed with regulators.

New phase III trial data from all three drugs was presented at The European Society of Cardiology congress in Stockholm at the beginning of September. One of the most important indications for the drugs is atrial fibrillation (AF). Analysts at Decision Resources say these and other anti-arrhythmic agents will increase the AF market more than eight-fold, from $843 million in 2009 to $6.8 billion in 2019. Analysts suggest the new drugs could earn as much as $10 - $20 billion overall if they successfully replace existing treatment warfarin.

Apixaban

The drug is an oral factor Xa inhibitor, and was discovered by Bristol-Myers Squibb and has been co-developed with Pfizer.

The latest data compared apixaban to aspirin in a phase III study for patients with atrial fibrillation who were intolerant to warfarin.

Data from the AVERROES trial showed apixaban reduced stroke rates by 52% in the 5,600 patients studied. This is an impressive percentage, although it should be noted that this was achieved in a small percentage of a small proportion of patients - down from a 3.3% risk on aspirin to 1.5% on apixaban.

Pfizer were keen to point out that this area remains as an unmet medical need as an estimated 40-50% of AF patients are either intolerant to warfarin or refuse to take the medicine, leaving them dependent on the less effective aspirin. This leaves a potentially lucrative commercial opportunity for the new product if apixaban can capture this particular market.

The results were so strong that the trial was stopped early in June. Apixaban will go head-to-head with standard treatment warfarin this year, with results from that trial expected in mid-2011. Analysts at Anderson forecast that the drug can reach annual global sales of $1.7 billion by 2015, making it one of the biggest new drug prospects in development.

Pradaxa

Boeringer Ingelheim’s Pradaxa (dabigatran etexilate) is up for review by regulatory advisers to the FDA on 20 September. Results from RE-LY showed that in patients with AF, Pradaxa significantly reduced the risk of stroke and systemic embolism by 34% compared to warfarin, but with comparable rates of major bleeding, the main sticking point in the trial.

The drug achieves the anti-thrombotic effects by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation.

The RE-LY trial generally impressed at the congress as it was the largest AF study ever completed to date, with enrollment of 18,113 patients, and produced strong reductions in stroke for AF when compared against warfarin.

Xarelto

Bayer/J&J’s Xarelto (rivaroxaban), another oral factor Xa inhibitor, produced strong results in dissolving blood clots in the legs and preventing new ones with a minimal level of side effects in VTE patients.

Bayer has said it expects peak sales of Xarelto to generate more than €2 billion ($2.5 billion) in annual sales.

The phase III EINSTEIN-DVT study showed non-inferiority compared to warfarin for the prevention of recurrent VTE in patients with acute symptomatic deep vein thrombosis (DVT).

The DVT study only showed Xarelto was as good as standard care in terms of efficacy, and came very close to statistically significant superiority, with recurrent clots occurring in 2.1% of patients on Xarelto compared with 3% in the control arm.

Bayer and J&J had already announced on 4 August that Xarelto was as “effective as the standard treatment of Sanofi’s injectable Lovenox”, followed by warfarin pills, but had not given precise data.

“It’s still an open race for Bayer,” analyst Karl-Heinz Scheunemann of LBBW told Reuters. “If Pradaxa gets FDA approval, I don’t see why Xarelto shouldn’t.”

Ben Adams

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