The US FDA has started the regulatory review process for Bristol-Myers Squibb and Pfizer’s anticoagulant Eliquis in a new indication that could provide a welcome boost to its sales momentum.
The regulator has accepted a filing for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
The oral Factor Xa inhibitor is licensed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), and is already approved for use in hip and knee surgery outside the US, including in the EU.
The application in DVT/PE comes on the back of three phase III trials – ADVANCE-1, ADVANCE-2 and ADVANCE-3 – and a decision is due by March 15 next year.
Trials are also ongoing in the treatment of DVT/PE – including the large-scale AMPLIFY study which was reported a couple of weeks ago – and these could lead to regulatory filings by the end of the year, according to BMS.
BMS and Pfizer said after the first quarter that sales of the drug were in line with expectations, but there are reports that overall take-up has not been as strong as hoped since its approval in the US right at the end of last year.
BMS posted Eliquis sales of $22m in the first quarter, although Pfizer did not break out quarterly figures for the drug, and all eyes will be on the release of sales figures for the first half of the year later this month.
BMS and Pfizer claim Eliquis has the best profile “across the axes of safety and efficacy” when compared to other anticoagulants that have come to market as oral alternatives to warfarin, namely Bayer’s Factor Xa inhibitor Xarelto (rivaroxaban) and Boehringer Ingelheim’s thrombin inhibitor Pradaxa (dabigatran).
Analysts have predicted that sales of Eliquis could reach $5bn a year at peak, but the slower-than-expected take-up has prompted some to take another look at their forecasts, at least in terms of the rate of growth.
Decision Resources said in March that it expects Eliquis and Xarelto to displace warfarin in the treatment and prevention of DVT/PE, with Xarelto becoming the market leader in the US thanks to an earlier launch that could give it market share of around 22 per cent by 2021. Eliquis will lag a little behind with around 19 per cent of the market, the analysts said.