The US Food and Drug Administration (FDA) has approved Merck’s human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, to be used as treatment for women and men aged from 27 years to 45 years.
Merck’s supplemental application has been approved to expand the use of Gardasil 9, which helps in preventing certain cancers and diseases caused by the nine HPV types covered by the vaccine.
As per the CDC, around 14 million Americans affected with HPV each year, and HPV viruses are associated with several other forms of cancer affecting men and women.
In 2006, Gardasil vaccine secured approval from the FDA to prevent cancers and diseases caused by four HPV types.
In 2014, Gardasil 9 received FDA approval to cover the same four HPV types, as well as additional five HPV types.
Gardasil 9 secured approval for use in males and females aged between nine years and 26 years.
Gardasil was 88% effective in preventing 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 in a study of around 3,200 women aged between 27 and 47 years.
FDA noted that the 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.
In addition, Gardasil 9 was assessed in around 13,000 males and females.
The FDA’s Center for Biologics Evaluation and Research director Peter Marks said: “Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range.
“The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”
In September this year, Merck’s anti-PD-1 therapy Keytruda was granted riority review designation by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma.
The company’s supplemental biologics license application (sBLA), which has been accepted by the regulator, is seeking accelerated approval for Keytruda to treat adult and pediatric patients with recurrent locally advanced or metastatic MCC.