FDA panel backs Chelsea's Northera

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 16-1 that the agency should approve Northera droxidopa from Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) to treat symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is Feb. 14. The vote comes despite briefing documents in which an FDA reviewer recommended a complete response letter for the orally available synthetic precursor of norepinephrine because there is "inadequate evidence of effectiveness" (see BioCentury Extra, Jan. 10). ...