Merck & Co., Inc. said the US Food and Drug Administration (FDA) has accepted, and designated for priority review, the supplemental Biologics License Application (sBLA) for Gardasil [Human Papillomavirus Quadrivalent] (Types 6, 11, 16, 18) Vaccine, Recombinant] for the potential use in women aged 27 through 45. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA's goal is to review and act on 90 percent of BLAs designated as priority review within six months of receipt.
Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16 and 18. Women remain at risk for newly acquired HPV infections and developing HPV-related diseases throughout their lifetime.
Gardasil is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine. It is not intended to be used for treatment of active genital warts; cervical cancer; CIN, vulvar interepithelial neoplasia (VIN), or vaginal interepithelial neoplasia (VaIN). Gardasil has not been shown to protect against disease due to other HPV types.
In clinical studies for Gardasil, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 per cent among recipients of Gardasil and also greater than those observed among recipients of placebo, respectively, were pain, swelling, erythema, fever, nausea, pruritis and dizziness. In addition, common post-marketing reports include vomiting and syncope.
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