Merck’s V116 Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Invasive Pneumococcal Disease & Pneumococcal Pneumonia
Shots:
- The US FDA has granted BTD to V116 (21-valent pneumococcal conjugate vaccine) for the prevention of IPD and pneumococcal pneumonia caused by multiple Streptococcus pneumoniae serotypes in adults aged ≥18yrs. The P-III trial of V116 is expected to be initiated in 2022
- The designation was based on the results from the two-part P-I/II (V116-001) study to evaluate the safety, tolerability, and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults aged 18-49yrs. (P-I) study and ≥50yrs. (P-II) study. The full results will be presented at the upcoming ISPPD in June
- V116 was designed to target serotypes that account for 85% of IPD in patients aged ≥65yrs. in the US
Ref: Businesswire | Image: Merck
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