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Merck's GARDASIL9 vaccine now approved by the US FDA for males 16 to 26 years to help reduce HPV-related diseases.

M2 EQUITYBITES-December 16, 2015-Merck's GARDASIL9 vaccine now approved by the US FDA for males 16 to 26 years to help reduce HPV-related diseases

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Healthcare company Merck (NYSE:MRK) reported on Tuesday that it has received US Food and Drug Administration (FDA) approval for an expanded age indication for its 9-valent human papillomavirus (HPV) vaccine, called GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant), to include males 16 to 26 years of age.

The company said GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) will now include use in males aged from 16 to 26 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 as well as genital warts caused by HPV types 6 and 11. GARDASIL 9 is already approved for use in boys nine to 15 years of age for the prevention of these diseases.

In conjunction, GARDASIL 9 is approved for use in girls and young women nine to 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 as well as genital warts caused by HPV types 6 and 11.

According to the company, GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) includes the greatest number of HPV types in any available HPV vaccine. It is available through its patient assistance programme for vaccines. It is covered under the CDC's Vaccines for Children (VFC) programme for both boys and girls

This clinical trial programme for GARDASIL 9 was designed to build upon the safety and efficacy established in clinical trials with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. A total of 1,106 heterosexual males and 1,101 females were enrolled in the study, added the company.

Concurrently, the primary analyses were conducted in the per-protocol population, in which study participants received all three vaccinations within pre-defined day ranges, did not have major deviations from the study protocol and were seronegative to the relevant HPV type(s) prior to dose one.

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