Pfizer, BMS face a delay on FDA’s megablockbuster decision on apixaban

Posted under apixaban, Blog, Bristol-Myers Squibb, Companies, Diagnostics, Eliquis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pradaxa, Startups, Universities, Videos, Warfarin, Xarelto by John Carroll

Pfizer ($PFE) and its partner Bristol-Myers Squibb ($BMY) will have to wait an extra few months before hearing whether the FDA will sign off on marketing approval for apixaban, their blockbuster anti-clotting hopeful.

In a brief release, the companies said they had submitted additional information for their NDA, which qualified as a "major amendment" that required added review time for the drug, dubbed Eliquis for commercial purposes. The new PDUFA date is now June 28 and the developers added that there are currently no plans for an advisory panel review.

The FDA had offered a priority review for apixaban in November as the partners hustled to reach the $9 billion market for anti-clotting drugs. If an approval comes through this summer, it will be a year after the EMA formally sanctioned the therapy. The delay also gives Boehringer Ingelheim and Bayer/J&J ($JNJ) more time to penetrate the market with their new therapies.

Analysts have given apixaban a solid shot at an approval, setting up a major showdown on the market with the arrival of a new treatment that is widely viewed as a major advance on warfarin, the old standard. Tim Anderson at Bernstein, who expects a panel review for apixaban, had estimated that the treatment could grab $395 million in sales this year and $3.7 billion by 2020. That initial timeline is likely to change a bit. Leerink Swann's Seamus Fernandez has estimated peak Eliquis sales at $4.2 billion in 2017.

For BMS, an approval would continue a regulatory streak that has included several key approvals. But for Pfizer, which has had a rocky road in the clinic, a megablockbuster OK would help redeem the company's tarnished reputation in R&D.

- here's the press release
- here's the AP report

Special Report: Eliquis - 15 top blockbuster contenders

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Pfizer, BMS drug Eliquis gets FDA priority review

Posted under apixaban, Blog, Bristol-Myers Squibb, Companies, Diagnostics, Eliquis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, Universities, Videos by Maureen Martino

The FDA has granted Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) priority review of the companies' anti-clotting drug Eliquis, promising a final ruling on the drug by March 28. The news comes a day after the U.K.'s cost effectiveness panel NICE gave the green light for Eliquis for preventing blood clots after hip and knee surgeries, just six months after the EMA approved the drug in Europe. 

Pfizer and BMS' application is based on two large studies of Eliquis for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Patients who received the new drug had better outcomes than those who got the standard treatment of warfarin. The two companies also reported that Eliquis cut the risk of stroke or systemic embolism 21%, major bleeding 31% and death 11%, as FierceBiotech noted in a recent report. 

If approved, Eliquis will compete with Boehringer Ingelheim's Pradaxa and the Bayer/Johnson & Johnson drug Xarelto for a slice of the $9 billion anti-clotting market. Though Pfizer and BMS' drug will likely be the last to be approved, analysts think Eliquis' favorable efficacy and safety profile could make it a leader in the field. It would also offer a much-needed boost to Pfizer, which suffered the loss of patent protection for its best-selling drug Lipitor this year.

- here's Pfizer's release on the FDA news
- see The Wall Street Journal report

Special Report: Eliquis - 15 top blockbuster contenders

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