FDA encourages gender research
Pharma companies must make sure it routinely analyses its data for gender-related differences in drug response, the FDA has said on its FDAVoice blog.
Sandra Kewer, the FDA’s Deputy Director of the Office of New Drugs, cited examples of two IBD drugs that had different responses in men and women.
Lotronex (alosetron), used in IBS, was only approved for women as clinical data showed it was not effective in men, Kewer said.
Another IBD drug, Giazo (balsalazide) treated