Gardasil prevents cervical, vaginal cancers in women of 27-45 age group too: Merck

Gardasil is currently approved for use in girls and women 9 to 26 years of age

Cervical cancer vaccine Gardasil could be effective in preventing cervical, vulvar, and vaginal cancers and precancerous or dysplastic lesions, and genital warts in women between the ages of 27 to 45. Read Cervical Cancer vaccine market hots up in India with Gardasil and Cervarix

Gardasil is currently approved for use in girls and women 9 to 26 years of age for the prevention of cervical, vulvar, and vaginal cancers; precancerous or dysplastic lesions, and genital warts caused by Human Papillomavirus Types (HPV) 6, 11, 16, and 18.

Gardasil helps protect against the four types of Human Papillomavirus Types (HPV), specifically types 6, 11, 16, and 18 that cause the most disease.

It is estimated that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancer cases and up to 50 percent of vulvar cancer cases.

Human Papillomavirus Types (HPV) types 6 and 11 cause approximately 90 percent of all genital warts cases.

At the completion of all pivotal clinical studies conducted in more than 20,500 young women aged 16 to 26 years of age over a period of three to four years, Gardasil prevented 98 percent of HPV 16- and 18-related cervical pre-cancers.

In the Phase III studies over a period of three years of more than 4,000 males ages 16 to 26, Gardasil was efficacious in reducing the incidence of genital warts related to HPV types 6 and 11 in males who were naïve to the relevant HPV type(s) 6, 11, 16, and 18.

Gardasil was 90.4 percent efficacious against HPV 6, 11, 16, and 18-related external genital lesions.

While the duration of protection of Gardasil has not been established, Gardasil has demonstrated efficacy through five years in the extension phase of a pivotal Phase II study of 551 women.

Gardasil is not recommended for use in pregnant women.

The most common adverse reaction was headache.  Common adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.

Gardasil is a ready-to-use, three-dose, intramuscular vaccine.  Gardasil should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

The first dose of Garadasil is administrered at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Gardasil (sold in some countries as Silgard) has been approved in 116 countries including India. Additional applications are currently under review with regulatory agencies in many more countries around the world.

Merck & Co provided US FDA with additional information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 to 45.

In January 2009 the U.S. Food and Drug Administration has issued a second complete response letter regarding the supplemental biologics license application (sBLA) for the use of Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45.

US FDA was reviewing the response that Merck provided in July 2008 and has recommended that Merck submit additional data when the 48 month study has been completed.

Merck’s initial sBLA included data collected through an average of 24 months from enrollment into the study, which is when the number of pre-specified endpoints had been met.

Global sales of Gardasil fell 22 percent to $311 million in the third quarter, hurt by overseas competition from GlaxoSmithKline’s rival Cervarix vaccine.

Merck reconfirmed its 2009 total sales (as recorded by the Company) guidance of $23.7 to $24.2 billion.

Gardasil, one of Merck’s biggest products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26.

In October last year,  Merck announced the U.S. Food and Drug Administration (FDA) has approved Gardasil for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

Merck & Co., Inc., is a global research-driven pharmaceutical company.