Boehringer submits Pradaxa antidote to regulators

A new product which can rapidly reverse the effects of Boehringer Ingelheim's (BI) anticoagulant Pradaxa has been filed with regulators in the US and Europe.

The drug, idarucizumab, is the first to be developed to provide an antidote to a novel oral anticoagulant (NOAC), the new class of treatments of which BI's Pradaxa is one.

Others in the market include Bayer and Johnson & Johnson's Xarelto, Pfizer and Bristol-Myers Squibb's Eliquis, and a new entrant, Daiichi Sankyo's Savaysa.

The drugs have been heralded as a major step forward in treating numerous conditions, including preventing blood clots after major surgery, and treating the serious heart condition atrial fibrillation, but concerns have also been raised about the raised risk of bleeding and strokes in patients.

BI's development offers patients who experience bleeding or risk of bleeding after taking Pradaxa another way of having it brought under control.

Professor Jörg Kreuzer, vice president, Medicine Therapeutic Area Cardiovascular at BI said idarucizumab would help in "rare emergency situations".

The need for antidotes for the new drugs led the US FDA to grant idarucizumab with a Breakthrough Therapy Designation, helping it to be developed and approved faster.

Concerns about the safety of Pradaxa have seen the drug lose market share to Bayer's similar treatment Xarelto. BI is continuing to carry out safety and efficacy studies for the drug, including two large real world studies released in November, which showed Pradaxa (dabigatran etexilate) to be associated with fewer major bleeds and strokes compared to warfarin.

Bayer saw Xarelto sales rise to €1.67 billion in 2014, up nearly 77 per cent. BI hasn't yet announced its annual results for 2014, but Pradaxa sales – which stood at €1.20 billion in 2013 – will be one of the key figures to watch out for on when results are announced on 22 April.