New Data Submitted to FDA by Merck for Wider Use of Gardasil

New Data Submitted to FDA by Merck for Wider Use of GardasilOn Wednesday, pharmaceutical company Merck & Co. confirmed that it has submitted new clinical data to the US Food and Drug Administration, with the hope that it will be allowed the expanded use of Gardasil, the cervical-cancer vaccine, in women who are aged between 27 and 45.

The data was submitted to the regulator before the end of 2009, as has been confirmed by the NJ-based drug maker on a posting on its official website.

Currently, Gardasil is approved for use in girls aged 9 to 26 years to help offer added protection against some forms of a virus that causes cervical cancer and some other serious diseases. Very recently, it was also approved for administration to males aged from 9 to 26 as a preventive measure against genital warts.

On a previous occasion as well, the company had sought FDA approval to allow women up-to the age of 46 to be vaccinated with Gardasil, but the regulator has delayed its awarding.

As confirmed by Merck spokeswoman Pamela Eisele, FDA has accepted the file with the latest data and Merck is expecting to hear back from the regulator before June, when a meeting has been scheduled with the vaccines advisory body to the U. S. Centers for Disease Control & Prevention.