logo
Plus   Neg
Share
Email
Comment

Bristol-Myers Squibb, Pfizer Get Complete Response Letter For ELIQUIS

Bristol-Myers Squibb Co. (BMY) and Pfizer (PFE) said the U.S. Food and Drug Administration or FDA has issued a Complete Response Letter relating to the New Drug Application or NDA forELIQUIS for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The Complete Response Letter requests additional information on data management and verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer would work closely with the FDA on the appropriate next steps for the ELIQUIS application. The FDA has not requested that the companies complete any new studies.

"There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation," said Elliott Sigal, Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb. The companies continue to progress the ELIQUIS application for stroke prevention in atrial fibrillation in markets outside of the U.S., including the European Union and Japan, based on the ARISTOTLE and AVERROES studies.

The companies are committed to an ongoing clinical development program for ELIQUIS, which is estimated to comprise nearly 60,000 patients globally across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Dish Network Corp. on Wednesday reported a surge in profit for the fourth quarter from last year, reflecting an income tax benefit that helped offset the impact of lower revenues. The latest quarter's results were positively impacted by an income tax benefit of about $1.2 billion due to an adjustment to deferred tax assets and liabilities related to tax reform legislation. Shares of Glencore plc were gaining around 4 percent in the morning trading in London after the producer and marketer of commodities reported Wednesday a significant growth in fiscal 2017 profit on strong higher commodity prices. Chief Executive Officer Ivan Glasenberg said, "Our performance in 2017 was our strongest on record, driven by our leading Marketing and Industrial asset businesses." Shares of Orange SA were gaining around 2 percent in the early morning trading in Paris after the French telecom major reported Wednesday a significant growth in fiscal 2017 profit from continuing operations with revenue growth in most regions, mainly France and Spain. In France, revenue grew for the first time since 2009. Attributable net income, meanwhile, declined on the absence of prior
comments powered by Disqus
Follow RTT