US FDA rejects CSL’s Gardasil for older women

Business Spectator

Published 1:53 PM, 7 Apr 2011

By a staff reporter, with Reuters

US regulators have turned down Merck & Co Inc’s bid to extend use of the CSL Ltd-developed cervical cancer vaccine Gardasil to older women.

The pharmaceutical giant had hoped to get approval for the vaccine to be used by women between the ages of 27 and 45.

Merck said that the Food and Drug Administration concluded that Gardasil has not been shown to prevent HPV-related cervical cancers in women over the age of 26 and the drug’s label has been updated to reflect that decision.

Gardasil is approved for use in girls and young women 9 through 26 years of age.

Merck has the rights to market Gardasil outside Australia, with royalties paid to CSL on sales made.

CSL received royalty payments of $45 million in the first half.

At 1340 AEST, shares in CSL had fallen 0.22 per cent to $36.46, against a 0.11 per cent drop in the benchmark index.


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.