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The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for V116, an investigational 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older.
The application is supported by data from several phase 3 studies in the V116 clinical development program. Specifically, the STRIDE-3 (ClinicalTrials.gov Identifier: NCT05425732) and STRIDE-6 (ClinicalTrials.gov Identifier: NCT05420961) studies, which evaluated the safety and immunogenicity of V116 in pneumococcal vaccine-naïve adults and adults 50 years of age and older who previously received a pneumococcal vaccination at least 1 year prior to study enrollment (n=717), respectively.
Findings from both studies demonstrated that V116 elicited robust immune responses in vaccine-naïve and previously vaccinated individuals. Among vaccine-naïve adults in STRIDE-3, V116 elicited noninferior immune responses compared with PCV20 (pneumococcal 20-valent conjugate vaccine) for serotypes common to both vaccines. The safety profile of V116 was comparable to the comparators (PCV20, PCV15 [pneumococcal 15-valent conjugate vaccine], or PPSV23 [pneumococcal 23-valent vaccine]) in both studies.
The Company will share additional findings from clinical trials at future congresses. A clinical program overview of V116 can be found here.
“If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease,” said Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”
A Prescription Drug User Fee Act target date of June 17, 2024 has been set for the application.
The FDA previously granted Breakthrough Therapy designation to V116 for this indication.
References:
FDA grants Priority Review to Merck’s new Biologics License Application for V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. News release. Merck. December 19, 2023. https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults/.
