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FDA knocks back Xarelto once again in ACS

Major setback for Bayer and Johnson & Johnson's oral anticoagulant

Bayer Xarelto rivaoxaban

In a huge setback for Bayer and Johnson & Johnson, US regulators have declined to approve their anticoagulant Xarelto as a treatment for patients with acute coronary syndromes (ACS) for a second time. 

The decision affects a large potential patient population for the drug and will make it harder for Xarelto to fulfil sales expectations. Bayer has previously tipped Xarelto to become a €2bn-plus product by 2015.

The US Food and Drug Administration (FDA) indicated via a Complete Response Letter (CRL) that once again it is unable to approve Xarelto (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in ACS patients, despite positive effects on survival in the ATLAS ACS 2-TIMI 51 trial.

The first CRL - sent in June 2012 - asked for additional safety data, and was delivered shortly after an FDA advisory committee narrowly voted against approval on the grounds of incomplete record-keeping in the pivotal trial which could have affected the survival data. 

Bayer and J&J said they were evaluating the latest CRL and "will respond to the agency's questions".

Xarelto is already approved for several indications in the US, including the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and to reduce the risk of stroke in people with non-valvular atrial fibrillation (AF), but approval in ACS could open up an additional $1bn market for the drug, according to analysts.

Bayer reported last week that sales of Xarelto outside the US reached €322m last year, a rise of almost 270 per cent. J&J did not break out Xarelto sales in its 2012 results, but indicated that growth was 40 per cent year-on-year.

Almost simultaneously with the latest CRL, the Journal of the American College of Cardiology published final results of a subpopulation study from the ATLAS ACS 2-TIMI 51 trial involving 7,800 patients with acute ST-segment-elevation myocardial infarction (STEMI).

The data showed that Bayer & J&J's factor Xa inhibitor cut the risk of cardiovascular death, secondary MI or stroke by 19 per cent compared to placebo, although Xarelto was associated with a significantly higher risk of major (non-fatal) bleeding episodes.

Bristol-Myers Squibb/Pfizer's Eliquis (apixaban) and Astellas' darexaban have both turned down by the FDA in ACS in the past because of bleeding complications.

6th March 2013

From: Sales



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