Merck files for licensure of V114 in U.S. and Europe

 

• Merck (NYSE:MRK) has submitted applications to the FDA and EMA for licensure of V114, its investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older for prevention of pneumococcal disease.
• The company awaits acceptance by the U.S. and European regulatory authorities.
• An overview of the late-stage development program for V114 is available here.
• V114 has previously secured accelerated review status in U.S. for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.
• https://seekingalpha.com/news/3638590-merck-files-for-licensure-of-v114-in-u-s-and-europe