SUNDAY, JUNE 24, 2018

FDA extends review of Gardasil for older recipients

The FDA announced last week that it would be extending its review of Merck's application to broaden the age range for Gardasil to include women between the ages of 27 and 45.

In 2006, the FDA approved the use of Gardasil for girls and young women between the ages of nine and 26. An expanded indication was approved in 2009 for males between the ages of nine and 26.

In its pending application, Merck argues that the benefits of Gardasil in the fight against HPV can be extended to older women to prevent cervical lesions from viral types that are responsible for a large portion of cervical cancers.

A decision by the FDA was originally expected this month, the Wall Street Journal reports, but the postponement means that a decision may now not be issued until the end of the year.

"We're continuing our dialogue with the FDA," Pam Eisele, a spokeswoman for Merck, told Eisele did not say why the FDA had extended the review timelines.

The delay, the FDA told, follows a request for more longer-term data on the efficacy of Gardasil after a follow-up of four years. The data was submitted to the FDA in late 2009 but has yet to be publicly disclosed.