GlaxoSmithKline and Genmab have announced that the FDA has informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months.
The BLA was submitted on January 30, 2009 and was granted priority review by the FDA. Under priority review, the FDA sets the target date for a decision at six months, rather than the standard 10 month review. The three month extension will allow the agency to review additional chemistry and manufacturing data submitted on 5 June. The new action date for the BLA is 31 October 2009.
GSK and Genmab said that they are committed to working with the FDA in order to bring this potential new treatment option to patients.