GardasilTreatment for Human Papillomavirus Prophylaxis
Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration
WHITEHOUSE STATION, N.J., February 7, 2006 -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) and that the investigational cervical cancer vaccine will be given priority review by the agency. A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), for BLAs filed in 2005, the FDA's goal is to review and act on BLAs designated as priority review within six months of receipt. The FDA has informed Merck that the review goal date is June 8, 2006.
Since submission to the FDA in December, Merck has also submitted applications for Gardasil to additional regulatory agencies including those in the European Union and Australia, Mexico, Brazil, Argentina, Taiwan and Singapore.
Gardasil is Merck's investigational cervical cancer vaccine. Gardasil is designed to protect against four types of human papillomavirus (HPV): types 16 and 18, which account for an estimated 70 percent of cervical cancer cases and HPV types 6 and 11, which account for an estimated 90 percent of genital wart cases.
In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in Gardasil. Gardasil is also the subject of other third-party licensing agreements.
About Cervical Cancer, HPV and Genital Warts
Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in a half-million diagnoses and approximately 300,000 deaths each year. In the United States an estimated 10,000 new cases of cervical cancer were diagnosed in 2005 and there were approximately 3,700 deaths. In most people, HPV goes away on its own. In some, however, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. In addition, certain low-risk types of HPV cause genital warts. Approximately one million cases of genital warts occur each year in the United States. Additionally, there are an estimated 4.7 million abnormal Pap results each year in the United States which require follow up. At least three million of these results are caused by some type of HPV.
Gardasil is one of three late-stage vaccines at Merck. In April, the Company submitted a Biologics License Application to the FDA for Zostavax, Merck's vaccine for zoster (shingles) and RotaTeq, Merck's vaccine for rotavirus gastroenteritis. RotaTeq was approved by the FDA on February 3 for the prevention of rotavirus gastroenteritis.
Source: Merck & Co., Inc.
Posted: February 2006
- FDA: Gardasil Approved to Prevent Anal Cancer - December 22, 2010
- FDA Approves Gardasil for Use in Boys and Young Men - October 16, 2009
- FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers - September 15, 2008
- FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases - June 8, 2006
- FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil - May 18, 2006
- Biologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track - February 2, 2006
- Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer - December 5, 2005
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