Update, March 1, 5 PM: Ramsay Baghadi of the RPM Report says that the Cardiorenal committee will take up the apixaban NDA on Mary 22 and the rivaroxaban supplemental NDA for the ACS indication on May 23, but this information has not been confirmed.
Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by three months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant Eliquis (apixaban). The application is for their important indication of stroke prevention in atrial fibrillation. The FDA had previously granted the application a 6-month priority review, resulting in a March 28th decision date. The new decision date is June 28,2012.
Sanford Bernstein research analyst Tim Anderson first raised the idea that the decision date might be delayed back on February 10th. On Tuesday Anderson released another note with additional evidence for the delay, based on the release of the tentative FDA advisory committee calendar for 2012, suggesting that the apixaban NDA will be subject to an advisory panel meeting. According to the calendar, the Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet on March 27 and May 23. The agenda for the March 27 session is already set for a discussion of Replagal for Fabry disease. Recall that yesterday the FDA granted a priority review to the NDA for rivaroxaban for ACS, resulting in a decision date of June 29. One might speculate then that another day might be added to the May 23rd meeting for consideration of the rivaroxaban and apixaban NDAs.
Anderson wonders why the FDA has suddenly put the brakes on the apixaban approval, which had heretofore seemed uncomplicated. He writes:
Our best guess remains that FDA may be seeking cover, given the safety experience following competing drug Pradaxa’s approval in 2010. Additionally, FDA may be seeking advice on things like product labeling and what claims would be allowed.
We might also note that the approval of rivaroxaban was far more difficult than had been expected. Remember that the ROCKET AF trial had been presented and published with broad approval, but then came under heavy fire from FDA reviewers. It is possible that FDA reviewers may also raise previously unsuspected concerns about the pivotal apixaban trial, ARISTOTLE, though no serious criticisms have been publicly raised so far.
Here is the press release from Pfizer and Bristol-Myers Squibb:
U.S. Food and Drug Administration Extends Action Date for ELIQUIS® (apixaban) by Three Months
PRINCETON, N.J. & NEW YORK–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for Eliquis® (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The new Prescription Drug User Fee Act (PDUFA) goal date is June 28, 2012.
Subsequent to the filing of the NDA, the companies submitted additional information about the Eliquis clinical program to the FDA, which constitutes a major amendment to the application and will require additional time for review. The companies will continue to work closely with the agency to support the continued review of the NDA for Eliquis.
At this stage there are no plans for an FDA advisory committee meeting to review the NDA for Eliquis.
About Eliquis
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the U.S. Eliquis is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for Eliquis in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Eliquis is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize Eliquis, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.
To learn more about our commitments, please visit us at www.pfizer.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that apixaban will receive regulatory approval for an indication in stroke prevention in patients with atrial fibrillation or that any such approval will be received within the time period described in this release. There is also no guarantee that, if approved in this indication, apixaban will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2011, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
PFIZER DISCLOSURE NOTICE:
The information contained in this release is as of February 29, 2012. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about various potential indications for ELIQUIS (apixaban), including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission and approval dates; decisions by regulatory authorities regarding whether and when to approve drug applications that have been or may be filed for any such indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such indications; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
[…] the pivotal ARISTOTLE trial was highly praised when it was first published, the FDA first extended its review by three months and then issued a complete response letter (CRL) on June 25 requesting “additional information […]