Bristol-Myers Squibb and Pfizer, Inc stock fell on Monday after the U.S. Food and Drug Administration unexpectedly delayed a decision for the second time on whether or not to approve Eliquis, an anti-clotting drug that is highly touted.
Some analysts say that Eliquis is better than new pills for clot preventing that beat the medication to the market. However, the most recent delay means the launch in the U.S. of Eliquis most likely will not take place until 2013.
Federal regulators said they wanted additional information on data verification and management from an international study titled ARISTOTLE that studied how successful Eliquis prevented strokes in people who had atrial fibrillation or an irregular heartbeat.
The two pharmaceutical giants said that the FDA did not request new studies, and the two will work quickly to address the regulators outstanding questions. Nevertheless, the Bristol-Myers spokesperson said the agency might take another six months to review the companies’ response after receiving it.
The spokeswoman said the companies were working with regulators to try to shorten the overall timeframe. One analyst, a University of Michigan professor Erik Gordon said if the FDA was requiring additional information on verification and data information, someone might have made a mistake in the application by not making sure the data management process was clear or messed up the actual data process.
The news impacts Bristol-Myers more because it is a much smaller company than Pfizer, which is the world’s largest drug maker. In addition, the FDA also delayed in January another decision on yet another experimental drug that Bristol is trying to get to market.