Sundry Photography Merck ( NYSE: MRK ) on Tuesday announced plans to seek regulatory clearance for its experimental therapy Clesrovimab to prevent respiratory syncytial virus (RSV) disease in infants after the monoclonal antibody succeeded in a Phase 2b/3 clinical trial. The U.S.
-based drugmaker’s goal signals a potential challenge to its European rivals, Sanofi ( SNY ) and AstraZeneca ( AZN ), which in 2023 won the FDA nod for Beyfortus as the first monoclonal antibody approved to protect infants against RSV disease. Citing topline results from its Phase 2b/3 MK-1654-004, Merck ( MRK ) said Clesrovimab met its primary safety and efficacy endpoints. The Rahway, New Jersey-based company added that it would share the detailed findings from the placebo-controlled study at a future medical event and use the data for regulatory filings with global healthcare authorities.
“We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families,” said Paula Annunziato, Merck’s ( MRK ) Therapeutic Area Head for Vaccine Clinical Development. More on Merck Merck: Positive Developments, But Watch The Q2 Earnings Merck: Among The Best Health Care GARP Plays Today Merck & Co., Inc.
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