FDA delays Eliquis approval
pharmafile | June 26, 2012 | News story | Sales and Marketing | BMS, Eliquis, FDA, Pfizer, Xarelto
The FDA has asked Pfizer and Bristol-Myers Squibb for more information about its key blood thinner Eliquis.
The US regulator has sent the firms a Complete Response Letter that requests more information on data management and verification from a key trial supporting the medicine.
Eliquis (apixaban) is seeking a new licence to prevent strokes in patients with atrial fibrillation.
This licence is potentially highly lucrative, meaning this decision will represent a major blow to both firms – analysts are predicting around $2 billion to $3 billion in peak annual sales for the drug by 2016.
The FDA’s decision could delay the drug’s approval by six to 12 months, and will be a boost to its rivals – Boehringer and its blood thinner Pradaxa, and Bayer/J&J’s Xarelto.
These two drugs have been on the US market for this condition since 2011 and 2010 respectively, and are looking to replace the 50-year-old warfarin.
But even though it will be late to the market, analysts still believe that Eliquis is clinically superior compared to its rivals, and expect the drug to do well should it meet approval.
“All of this [delay] is surprising given the widespread perception that Eliquis is a best-in-class product relative to already-approved novel oral anticoagulants Pradaxa and Xarelto,” Sanford Bernstein analyst Tim Anderson said in a research note.
The FDA fell short of asking for the firms to do new clinical trials, which would have further delayed approval.
The firms said in a statement that they “will work closely with the FDA on the appropriate next steps for the Eliquis application”.
Elliott Sigal, executive VP of Bristol-Myers Squibb, said: “We believe that the two large trials called ARISTOTLE and AVERROES have established the therapeutic profile for Eliquis and demonstrated a meaningful advance over the standard of care.”
The drug is also under review by the European Medicines Agency, who is expected to make a decision by the end of the year.
Industry analysts EvaluatePharma said that a full approval of the NDA had widely been expected by the 28 June action date, and said the complete response letter has come ‘as a nasty surprise’.
The two companies have a 50/50 profit-sharing deal, and EP says they must now work quickly to minimise the launch delay if they are to have a chance of competing seriously in the stroke prevention space.
Ben Adams
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
