Pfizer’s Eliquis Vies For FDA Approval With Encouraging Results In Recent Study

by Trefis Team
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Pfizer (NYSE:PFE) has a new reason to cheer. In a recent phase III clinical study, its blockbuster potential drug Eliquis, compared with a placebo, managed to significantly reduce blood clots risks in patients suffering from venous thromboembolism or VTE (a blood clot within a vein). [1] The outcome will certainly help Pfizer’s Eliquis to get access to much larger markets. Also, last month Pfizer received European Medicines Agency’s (EMA) approval for expanding the use of Eliquis to nonvalvular atrial fibrillation or NVAF (irregular heart beat) patients (Read Pfizer Update: Europe Approves Eliquis For Atrial Fibrillation). However, the drug still has to get U.S. FDA approval to achieve its full sales potential with entry into the U.S. market. Here we take a detailed look at the drug and its prospects.

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About Eliquis

Eliquis (Apixaban) is a drug used in blood thinning and is part of the antithrombotic family, which helps prevent clotting that can restrict blood circulation to the organs. Besides recent European approval for NVAF, the drug is currently approved in many countries (excluding the U.S.) for preventing blood clots in patients who have knee or hip replacements.  Eliquis is the most promising drug for Pfizer’s cardiovascular division, which has been grappling with patent expiries of major drugs including Lipitor (Read Pfizer Patent Cliff: A Look At The Cardiovascular Drugs Division).

The blockbuster potential drug is expected to garner as much as $3 billion in peak sales. However, much of it depends on the U.S. FDA approval and the drug’s extension to treatment for VTE and acute coronary syndrome (related to the blockage of coronary arteries), which affects millions of patients worldwide each year. The FDA has turned down the drug two times earlier but is expected to take a decision on Eliquis by March 2013. [2] However, we think Eliquis has a decent chance of being approved considering the fact that it is already approved in Europe and there are impressive results from clinical trials to lend support it.

Impressive Results Strengthen Eliquis’ Bid

The ARISTOTLE trial demonstrated that Eliquis significantly reduced the risk of a stroke or systematic embolism by 21% compared with warfarin, a standard treatment. In a separate AVERROES trial for non eligible patients for warfarin, the drug showed similar positive results in safety and efficacy. Eliquis reduced relative risk of a composite stroke or systematic embolism by 55% over aspirin, without a significant increase in major bleeding. [3] Bleeding is a major side effect of blood thinning drugs, sometimes leading to death. Side effects are one of the biggest factors determining a drug’s future.

However, any major delay in approval would further strengthen the foothold of its closest rivals Johnson & Johnson‘s (NYSE:JNJ) Xarelto and Boehringer-Ingelheim’s Pradax, which have already been approved for atrial fibrillation patients. Further, J&J has resubmitted clinical trials data in a bid to convince the U.S. FDA to approve the expanded use of Xarelto by acute coronary syndrome patients (to prevent heart attack and stroke in patients who have previously had severe chest pain or heart attack). But when approved we expect Eliquis sales to see strong rise as the drug has exhibited significant safety over other two non-warfarin drugs (Xarelto and Pradax). Pfizer’s strong cardiovascular marketing force (Lipitor) will also come handy in pushing the drug.

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Notes:
  1. Pfizer, Bristol-Myers Blood Thinner Cuts Risk of Clots in Study, Nasdaq, Dec 8 2012 []
  2. FDA Sets New Decision Date For Eliquis (Apixaban), Forbes, Sep 27 2012 []
  3. Apixaban for Stroke Prevention in Atrial Fibrillation, Hospital Practice, Oct 2011 []
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