Eliquis fails in head-to-head study against Lovenox
Bristol-Myers Squibb and Pfizer have suffered a setback in their attempts to cement Eliquis’ place in the $20 billion market for new oral anticoagulant therapies.
New data from the Phase III ADOPT trial shows that oral Eliquis (apixaban) has come up short against Sanofi’s injectable anticoagulant Lovenox (enoxaparin), which succumbed to generic competition last year.
ADOPT pitted the two against one another in acutely ill patients who had been hospitalised for heart or respiratory failure and other serious illnesses.
In the study Eliquis did not meet the primary efficacy outcome of superiority over Lovenox for the endpoint of venous thromboembolism (VTE) and VTE-related death after 30 days.
The endpoint occurred in 2.7% of patients in the Eliquis group and 3.1% of those in the Lovenox arm.
The FDA is expected to make a decision on whether to accept Pfizer and BMS’ filing for Eliquis in stroke prevention and AF by the end of the year, an indication in which it is also up for review by the EMA.
The drug was approved by the European regulator for the prevention of venous thromboembolic events in patients who have undergone elective total hip or knee replacement surgery in September.
This is a blow for the manufacturers as Eliquis is one of three new pills aiming to supplant Lovenox and the much older oral treatment warfarin. The others are Bayer/J&J’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran).
In contrast Xarelto has just been boosted by its new study that shows the drug significantly reduced cardiovascular death, heart attack and stroke in patients with acute coronary syndrome compared to standard treatments.
J&J and Bayer were also bolstered this month when the FDA approved the drug for stroke prevention in patients who have non-valvular atrial fibrillation (AF).
This came after the US regulator gave Xarelto a green light to reduce the risk of blood clots, deep vein thrombosis and pulmonary embolism following knee or hip replacement surgery in July.
Twice-daily pill Pradaxa stole a march on both treatments in October last year, gaining FDA approval for stoke prevention in AF patients.
The ADOPT results, presented at the annual American Heart Association Scientific Sessions in Orlando, were published in the New England Journal of Medicine.
The Eliquis arm had a 13% lower rate of events than Lovenox, but this was not statistically significant. Major bleeding was low in both groups but higher in patients treated with Eliquis (0.47%) versus those in the Lovenox group (0.19%).
ADOPT is not the only avenue being investigated by BMS/Pfizer, with Eliquis being evaluated in the Phase III AMPLIFY and AMPLIFY-EXT trials for the treatment of recurrent VTE.
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