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Pfizer, BMS say Eliquis review delayed in US

While Pristiq dropped by Pfizer for menopause symptoms

Pfizer and partner Bristol-Myers Squibb (BMS) have said that the US Food and Drug Administration (FDA) is extending the deadline to review Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation by three months.

The purpose of the extension is to give the agency more time to look at a "major amendment" to the dossier, giving additional information about the clinical trials programme for the anticoagulant.

The application had originally been given a fast-track review by the FDA.

Eliquis was approved in the EU last year for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery, and has not been registered for use in atrial fibrillation anywhere in the world.

There had also been speculation that the FDA would ask an advisory committee to review the Eliquis data, but in a statement Pfizer said: "at this stage, there are no plans" for such a meeting.

At the time Eliquis was fast-tracked, Deutsche Bank analysts predicted 2012 sales of $250m for Eliquis, rising to $2.5bn at peak, making Eliquis a critical product for both Pfizer and BMS as they try to cope with patent losses on top-selling brands.

Pristiq dropped for menopause
Meanwhile, Pfizer has withdrawn its marketing application in the US seeking to extend the use of its antidepressant Pristiq (desvenlafaxine) for menopausal symptoms in women.

Pristiq was approved for sale in the US in 2008 as a treatment for major depressive disorder, and has made reasonable headway in the crowded market for antidepressants, gaining a 24 per cent increase in sales to $577m last year.

Much of the product's earlier promise had been related to its potential to treat moderate-to-severe vasomotor symptoms such as hot flushes in menopausal women, however, a sector that could have boosted peak annual sales to the $2bn region.

The withdrawal of the New Drug Application (NDA) in the US does not come as a huge surprise, given that the drug's original developer Wyeth (acquired by Pfizer in 2009) had already decided to pull its European filing for this indication.

In 2008, after it became apparent additional clinical trials would be needed to support approval in the menopausal setting, Wyeth elected not to proceed with this application as well as its filing for depression.

Pristiq did reach the market for menopausal symptoms in some other countries, such as Mexico, but any significant growth contribution from this indication is unlikely in the absence of US approval.

1st March 2012

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