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The US Food and Drug Administration approves the expanded use of Gardasil 9.

M2 PHARMA-October 8, 2018-The US Food and Drug Administration approves the expanded use of Gardasil 9


Public health agency the US Food and Drug Administration announced on Friday that it has authorised the supplemental application for Gardasil 9, to expand the use of the vaccine to help prevent certain cancers and diseases caused by the nine HPV types to include women and men aged 27 to 45 years of age, through its priority review status.

The US FDA has granted approval of this supplement to the Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co Inc.

According to the CDC, every year about 14 million Americans become infected with HPV. About 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

In conjunction, the safety of Gardasil 9 was evaluated by Merck in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years.

Under the study, Gardasil was 88% effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions and cervical cancer related to HPV types covered by the vaccine. The US FDA approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

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Publication:M2 Pharma
Date:Oct 8, 2018
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