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Daiichi files new anticoagulant edoxaban in US and EU

Seeks approvals in atrial fibrillation and venous thromboembolism
Daiichi Sankyo logo

Japan's Daiichi Sankyo has filed for approval of its once-daily anticoagulant edoxaban on both sides of the Atlantic for the management of patients with atrial fibrillation (AF) and venous thromboembolism (VTE).

Edoxaban is one of a clutch of novel oral anticoagulants (NOACs) aiming to unseat injectable warfarin as the primary drug in these settings, and if approved will compete with agents such as Pfizer and Bristol-Myers Squibb's twice-daily Eliquis (apixaban) and Bayer's once-daily Xarelto (rivaroxaban), as well as rival drug Pradaxa (dabigatran) from Boehringer Ingelheim.

The drug is a Factor Xa inhibitor - in the same class as Xarelto and Eliquis - and has been available in Japan under the Lixiana brand since 2011 for the prevention of VTE in patients undergoing orthopaedic surgeries. Its proposed trade name in the US is Savaysa, and Daiichi is hoping to launch the drug in the US and Europe before the end of fiscal 2014.

Daiichi is seeking approval of edoxaban on the strength of the ENGAGE -AF and Hokusai-VTE trials, which showed that the drug was non-inferior to injectable warfarin and was significantly less likely to cause clinically-relevant bleeding, although like other NOACs it is associated with higher rates of gastrointestinal bleeding than warfarin.

The new agents also require less monitoring than warfarin, and one of the primary areas where they are used is in patients who find their coagulation measures fluctuate a lot over time.

The NOACs are expected to make steady headway against warfarin and help drive the value of anticoagulant market to more than $11bn in 2015, although for many patients around the world the older, cheaper drug remains a suitable option if coagulation scores are well-controlled.

The prevention of stroke in AF patients will be the main market for the new drugs, accounting for around 70 per cent of total sales in developed markets, according to Decision Resources.

In a recent report it predicts that sales in the US, France, Germany, Italy, Spain, the UK and Japan will swell from $3.4bn last year to $8.6bn in 2020, with a contraction thereafter as generic versions of Pradaxa and Xarelto start to appear on the market.

Decision Resources sees Eliquis dominating the market by 2020 with sales of $2.7bn, followed by Xarelto with $2bn and edoxaban trailing, although other analysts have suggested Daiichi Sankyo's drug has a profile that could allow it to capture a 15 per cent share of the global market, worth around $3bn a year.

Article by
Phil Taylor

13th January 2014

From: Research

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