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FDA to assess safety of Boehringer's Pradaxa

US regulator plans study to compare the anticoagulant with warfarin

Boehringer Ingelheim's Pradaxa (dabigatran)Authorities in the US are to launch a safety assessment of Boehringer Ingelheim's anticoagulant Pradaxa.

The US Food and Drug Administration (FDA) plans to launch a large-scale study that will compare Pradaxa (dabigatran) – one of a new generation of bloodthinners launched in recent years – with the previous standard treatment warfarin, according to a report by Forbes.

Specifically, the study intends to assess safety outcomes, such as bleeding and thromboembolic events, in adults with atrial fibrillation (AF) who are new users of either product.

The announcement comes more than three years after Pradaxa was first approved in the US to prevent stroke in patients with AF.

Since then it has become one of Boehringer's leading new products, reaching global sales of more than €1.1bn in 2012 despite competing with two other new anticoagulants: Bayer/Johnson & Johnson's Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer's Eliquis (apixaban).

Announcing the safety study, the FDA said: “Questions remain, however, about the outcomes associated with dabigatran outside of the clinical trial setting and in typical clinical practice populations.”

As such, the assessment will make use of real-world data via the Mini-Sentinel programme – a pilot project sponsored by the FDA to “inform and facilitate development” of the Sentinel System, which was launched in 2008 to monitor the safety of FDA-regulated medical products.

The Sentinel Initiative is part of the agency's efforts to develop a national electronic system that uses pre-existing electronic healthcare data from several sources. The Mini-Sentinel programme has 17 data partners and uses data from 100 million patients.

So far, the FDA has not announced plans to assess the safety of either Xarelto or Eliquis.

Article by
Thomas Meek

6th January 2014

From: Sales, Regulatory, Healthcare



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