Baxter International Inc. (BAX: Quote) and Halozyme Therapeutics Inc. (HALO) announced that the U.S. Food and Drug Administration is requesting additional information to complete its review of the HyQ Biologics License Application or BLA.
Baxter and Halozyme said that they will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. The companies now expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data.
The companies expect these requests to require additional time to complete and to delay the companies' anticipated regulatory review and approval timeline.
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by RTT Staff Writer
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