Merck (NYSE: MRK) shares were singing Wednesday, on word of new developments on the medication front.
The U.S. Food and Drug Administration (FDA) has reportedly accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children six weeks through 17 years of age.
The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA set a Prescription Drug User Fee Act, or target action date, of April 1, 2022.
"VAXNEUVANCE has the potential to provide meaningful protection against invasive pneumococcal disease for children and infants by targeting pneumococcal strains, or serotypes, that contribute to substantial disease burden, including serotype 3, and broadening coverage to additional disease-causing serotypes, 22F and 33F, which are not included in the pneumococcal conjugate vaccine (PCV) currently available for this population," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
The sBLA is supported by results from Phase 2 and Phase 3 clinical studies in pediatric populations including infants, children, and adolescents. These studies support the potential use of VAXNEUVANCE in a variety of clinical settings, including immunization of infants and toddlers as well as of special populations at increased risk for pneumococcal disease, such as children with HIV infection or sickle cell disease.
MRK shares hiked $1.27, or 1.7%, to $76.18.
