Cidara Therapeutics & Mundipharma received a Positive opinion from the EU’s CHMP for Rezzayo (Rezafungin) to Treat Invasive Candidiasis
Shots:
- The positive opinion was based on a P-III (ReSTORE) evaluating the safety & efficacy of Rezafungin vs SoC (caspofungin) on patients with invasive candidiasis in 1:1 ratio
- The results of 1EP of the study showed a day 14 global cure rate of 59.1% vs 60.6% & the result of 2EP includes day 5 Mycologic eradication of 78.1% vs 68.7%; day 5 global cure of 55.9% vs 52.1%; day 14 mycologic eradication of 71.9% vs 70.1%
- Additionally exploratory endpoint showed day 1 -ve blood culture in 53.7% vs 46.2%; day 2 -ve blood culture in 74.2% vs 64.1% along with median ICU stay length of 5 vs 14.5 days
Ref: Cidara Therapeutics | Image: Cidara Therapeutics
Related News:- Cidara Entered into a License Agreement with Melinta to Commercialize Rezafungin for Candidemia and Invasive Candidiasis in the US
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.