FDA to review Xarelto safety concerns
pharmafile | March 19, 2009 | News story | Research and Development, Sales and Marketing |Â Â XareltoÂ
Anti-blood clotting drug Xarelto could fail to win approval in the US due to safety concerns.
The FDA has convened an outside panel to review the drug's risk-benefit profile today in light of evidence presented earlier this week, according to Associated Press.
On 17 March FDA staff raised concerns about data on the drug which suggests it significantly increases the risk of bleeding in patients compared to an established rival treatment.
The news has come as a surprise to Johnson & Johnson and Bayer, who co-market the drug, as Europe's regulator approved the drug in October.
An FDA committee briefing stated that that Xarelto "could lead to bleeding events in significantly more patients" than Sanofi-Aventis' Lovenox (known as Clexane in the UK).
The note added the evidence "amplifies this safety concern" for Xarelto, which could mean restrictions on its use or even a rejection by the FDA.
If approved the drug will be marketed by Johnson & Johnson in the US, who jointly developed the drug with Bayer, who market Xarelto in Europe.
Xarelto's first licensed indication is to prevent venous blood clots in patients undergoing elective hip or knee replacement surgery, one of the most common causes of potentially fatal blood clots.
The drug's European launch in October 2008 was a major event for Bayer, which predicted it could one day reach blockbuster status, with peak sales of more than 2 billion euros in a variety of indications. NICE has also already given preliminary approval for the drug's use on the NHS.
Clexane is the current gold-standard treatment for the indication, and is injected for at least six days after an operation until the patient starts walking again. But its injectable formulation makes it inconvenient when longer-term treatment is required.
Xarelto holds an advantage in that is it an oral treatment. Bayer and Johnson & Johnson say data shows Xarelto to be significantly more effective than Clexane in preventing blood clots, potentially helping to prevent many deaths, and these benefits outweigh the increased risks of bleeding.
Also, Johnson & Johnson said it would take steps to monitor potential problems after approval.
The FDA will seek advice from its panel of external experts before making its decision. It usually follows the panel's recommendations.
The setback to Xarelto will be good news for Boehringer Ingelheim, who market rival treatment Pradaxa.
Launched last year by Boehringer Ingelheim. The drug has already secured NICE recommendation in the UK.
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