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Find Clinical Drug Pipeline Developments & Deals by Mundipharma
The payment triggered under the agreement is following the European approval of Rezzayo (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.
Rezzayo (rezafungin) is an echinocandin antifungal indicated in patients 18 years of age
or older who have limited or no alternative options for the treatment of
candidemia and invasive candidiasis.
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia.
CD101 (rezafungin) is a novel, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections,demonstrated non-inferiority to the current standard of care in the treatment of candidemia and/or invasive candidiasis.
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.
European Medicines Agency filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin (echinocandin/CD101) demonstrated non-inferiority to the current standard of care, caspofungin in the treatment of candidemia and/or invasive candidiasis.
Results from ReSTORE showed primary endpoints were met with, 23.7% all-cause mortality on day 30 for rezafungin compared to 21.3% for caspofungin global cure on day 14 of 59.1% for rezafungin and 60.6% for caspofungin.
Result, did not demonstrate highly potent antifungal properties of CD101 against Candida in preclinical animal models of VVC, CD101 IV has enhanced potency and is only once-weekly therapy intended for treatment and prevention of life-threatening invasive fungal infections.
PIM designation, early indication that CD101, next-generation echinocandin may be eligible for Early Access to Medicines Scheme in UK permits use of medicines not yet approved by regulatory authorities for treatment of invasive candidiasis and candidemia.
Rezafungin is a novel once-weekly echinocandin currently being studied in Phase 3 trials for the treatment and prevention of serious fungal infections in critically ill patients.
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