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Portola rejection hands advantage to Boehringer's Pradaxa

FDA’s ruling on reversal agent for NOACs unexpected

FDA headquarters 

The FDA's surprise rejection of Portola's reversal agent for the Factor Xa inhibitor class of novel oral anticoagulants (NOACs) could be a boost for a rival drug from Boehringer Ingelheim.

The US regulator turned down Portola's application to market AndexXa (andexanet alfa) as an antidote to three direct Factor Xa inhibitors - Pfizer/Bristol-Myers Squibb's Eliquis (apixaban), Bayer/Johnson & Johnson's Xarelto (rivaroxaban) or Daiichi Sankyo's Savaysa (edoxaban) - as well as generic indirect inhibitor enoxaparin. 

Portola was seeking approval for use of its drug when patients receiving the NOACs experience a life-threatening or uncontrolled bleeding incident, but the FDA has said it needs additional information from the company on manufacturing as well as the inclusion of recently-approved edoxaban and enoxaparin on the label.

The agency said that it also needs more time to complete its review of certain clinical amendments to Portola's post-marketing commitments that were submitted recently.

Shares in Portola plunged on news of the FDA rejection, and the company is holding an investors briefing this morning to give more information on the status of the programme. 

It is not yet clear how long the drug may be delayed, but in the meantime Boehringer's rival NOAC Pradaxa (dabigatran) - which works by inhibiting thrombin - remains the only new anticoagulant on the market with a reversal agent available.

That will be a boon for the privately-held German company, which needs Pradaxa to continue to grow while it weathers the onset of generic competition to its top-selling drug, Spiriva (tiotropium) for chronic obstructive pulmonary disorder (COPD). 

In October 2015 the FDA granted accelerated approval to Boehringer's Praxbind (idarucizumab) reversal agent for Pradaxa, which seems to have had an impact on sales of the NOAC. After flat sales growth towards the end of 2015, Pradaxa bounced back with a 6% gain in the first six months of 2016, adding €650m to the German group's revenues.

The thrombin inhibitor is still lagging well behind the market leader in the NOAC category - Xarelto - that saw sales leap last year. J&J reported its sales of the drug rose 23% to $1.87bn, while Bayer said its revenues for the drug were up 34% to €2.25bn ($2.55bn).

Article by
Phil Taylor

19th August 2016

From: Research, Regulatory

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