Pfizer Secures Coveted FDA Approval For Eliquis

Pfizer (NYSE:PFE) has received a major boost as its blockbuster potential blood thinner drug Eliquis has received coveted U.S. FDA nod for patients with atrial fibrillation, which is not caused by a heart valve problem. ^[1] The much anticipated approval adds to recent positive developments around the drug and will open much larger U.S. market that has evaded the drug until now. Last week, the drug secured Japan’s approval for expanding the use to non-valvular atrial fibrillation or NVAF (irregular heart beat) patients. Eliquis had already received European Medicines Agency’s (EMA) approval for the similar indication last month (Read Pfizer Update: Europe Approves Eliquis For Atrial Fibrillation).

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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. Along with aforementioned approvals, Eliquis is already approved in many countries (excluding the U.S.) for preventing blood clots in patients who have knee or hip replacements. The FDA, which has turned down the drug two times earlier, was expected to take a decision on Eliquis by March 2013. ^[2] However, an early approval will help the drug take on its closest rivals Johnson & Johnson‘s (NYSE:JNJ) Xarelto and Boehringer-Ingelheim’s Pradax, which have already been approved for atrial fibrillation patients.

This  however, is only a halfway for Eliquis, which is expected to garner as much as $3 billion in peak sales. The drug will not be able to achieve its full sales potential without its extension to treatment for VTE and acute coronary syndrome (related to the blockage of coronary arteries), which affects millions of patients worldwide each year. We, however, see recent impressive clinical results as a positive sign for approval. Last month, Eliquis, when 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). ^[3]

But, the timing of these pending approvals will matter as J&J has already 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).  However once approved for other indications, we expect Eliquis sales to see strong rise as it has exhibited significant safety over warfarin and aspirin (ARISTOTLE and AVERROES trials) in reducing the risk of stroke, and dangerous blood clots without a major bleeding amongst all non-warfarin drugs, including Xarelto and Pradax. ^[4] 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. Pfizer’s strong cardiovascular marketing force (Lipitor) will also come handy in pushing the drug.

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1. FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation, FDA, Dec 28 2012 [↩]
2. FDA Sets New Decision Date For Eliquis (Apixaban), Forbes, Sep 27 2012 [↩]
3. Pfizer, Bristol-Myers Blood Thinner Cuts Risk of Clots in Study, Nasdaq, Dec 8 2012 [↩]
4. Apixaban for Stroke Prevention in Atrial Fibrillation, Hospital Practice, Oct 2011 [↩]