The US Food and Drug Administration (FDA) has accepted the new biologics licence application (BLA) for MSD’s investigational 21-valent pneumococcal conjugate vaccine, V116, for priority review.
The vaccine is intended to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
The regulatory agency will give its decision on 17 June 2024 under the Prescription Drug User Fee Act.
MSD’s application is partially based on findings from the Phase III STRIDE-3 clinical trial that analysed the safety, immunogenicity and tolerability of V116 versus PCV20 pneumococcal 20-valent conjugate vaccine in adults who have not previously received pneumococcal vaccination.
Additional data from Phase III studies, including STRIDE-4, STRIDE-5, and STRIDE-6, further support the vaccine use in vaccine-naïve and vaccine-experienced adults.
V116 is administered as a single dose.
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MSD Research Laboratories’ global clinical development head, senior vice-president and chief medical officer Dr Eliav Barr stated: “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines.
“If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.
“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.”
The latest development comes after the European Commission approved the company’s Keytruda plus chemotherapy for two indications in gastrointestinal cancers.
The combination regimen is approved as first-line therapy for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Keytruda plus gemcitabine and cisplatin is indicated as first-line therapy in adults with locally advanced unresectable or metastatic biliary tract carcinoma.