Specifically, the ACIP voted to recommend a single dose of Capvaxive for:
Additionally, shared clinical decision-making is recommended regarding the use of a supplemental dose of Capvaxive for adults 65 years and older who have completed their vaccine series with both PCV13 and PPSV23.
The European Commission (EC) will now review the CHMP recommendation. The EC’s decision on Winrevair’s marketing authorization application is expected in the third quarter of 2024.
The CHMP recommendation is based on data from the Phase 3 STELLAR trial of Winrevair on top of background PAH therapy compared to background therapy alone.
Winrevair demonstrated a statistically significant and clinically meaningful improvement in the 6-minute walk distance, the study’s primary endpoint, and on multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events.
Also Read: FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug.
Price Action: MRK shares were trading higher by 0.13% at $129.99 premarket at the last check on Friday.
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