Reuters: Regulatory News: UPDATE 1-Bristol/Pfizer clot preventer delayed in U.S.

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UPDATE 1-Bristol/Pfizer clot preventer delayed in U.S. Jun 25th 2012, 12:36 Mon Jun 25, 2012 8:36am EDT * FDA does not request additional studies * Eliquis one of three new blood clot drugs * Bristol shares fall 5.1 pct, Pfizer down 2.3 pct June 25 (Reuters) - A closely watched blood clot preventer from Bristol-Myers Squibb Co and Pfizer Inc has failed to win approval from U.S. health regulators, the companies said on Monday. Shares of Bristol fell more than 5 percent in premarket trading after the news about the drug, Eliquis, which is thought to be a potential multibillion-dollar product. Pfizer shares dropped more than 2 percent. Investors have been waiting for a decision on Eliquis by the Food and Drug Administration by the end of the month. The pill is designed to prevent strokes and clots in patients with a dangerously irregular heartbeat called atrial fibrillation. Eliquis, also known as apixaban, has been envisioned as the potential leader of three new blood clot treatments meant to replace warfarin - the longstanding oral standard of care for the condition. The FDA notification on Eliquis did not require the completion of any new studies, the companies said, which could mean only a modest delay before the drug wins approval. Rather, the agency's complete response letter requested more information on data management and verification from a key clinical trial supporting the medicine. "FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward," the companies said in a statement. The FDA granted an expedited review to Eliquis last November, based on its clinical data. But in March, the companies said the agency had postponed acting on the application for three months, resulting in the current deadline. If approved for stroke prevention, Eliquis would compete against two other recently approved blood clot preventers: Xarelto, from Johnson & Johnson and Bayer, and Pradaxa, from Boehringer Ingelheim. ISI Group analyst Mark Schoenebaum said Bristol and Pfizer are likely seeking the ability to claim Eliquis is safer and more effective than warfarin "something that no other blood thinner has." He speculated the FDA is being "extra cautious" in evaluating this claim. The analyst predicted that the companies would respond to the agency by the end of the year, with the drug winning approval by the middle of 2013. Bristol shares dropped 5.1 percent to $33.55 in premarket trading, while Pfizer shares fell 2.3 percent to $22.20. Link this Share this Digg this Email Reprints

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