FDA expands male age indication for Merck's Gardasil 9
The Kenilworth, NJ-based pharma giant said Gardasil 9 received an expanded age indication from the FDA covering males 16 through 26 years of age for the prevention of anal cancers and genital warts stemming from 9 HPV types. Since the vaccine was previously indicated for boys 9 to 15, the new approval aligns both the male and female indications at ages 9 to 26.
The expanded approval is a boost as Merck ($MRK) works to position the vaccine as the cornerstone of its vaccines unit since its approval last December. Covering more HPV types than any other available vaccine, Gardasil 9 is expected to reach $1.9 billion in annual sales, though much of that is expected to come at the expense of its predecessor Gardasil.
Getting there will be a challenge, though, as Merck and Cervarix-maker GlaxoSmithKline ($GSK) have encountered significant barriers to uptake with the vaccine class such as a sex stigma, reimbursement woes for boys, safety concerns and misleading medical information discouraging vaccination.
After receiving its FDA approval late last year, Gardasil 9 got its next boost from the CDC's Advisory Committee on Immunization Practices, which in February recommended it as one of three HPV vaccines that can be used for routine vaccinations. Then in June, the shot received a regulatory blessing from the European Commission.
According to research published in Cancer Epidemiology, Biomarkers & Prevention, the vaccine has the potential to prevent 90% of cervical cancers and help prevent other associated cancers.
- here's the release
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