Merck wins breakthrough therapy designation for potential pneumococcal vaccine successor
Less than a year after winning FDA approval for its next-generation pneumococcal vaccine last July, Merck is already impressing the agency with a potential follow-up program.
Regulators bestowed breakthrough therapy designation upon Merck’s V116 candidate, a 21-valent vaccine designed to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. Merck had turned in data from a randomized Phase I/II trial in patients 18 and up for the agency’s review, and Phase III clinical trials for V116 are to be initiated later this year, the pharma said.
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