European approval of Rezzayo (rezafungin) for the treatment of invasive candidiasis in adults.- Cidara Therapeutics + Mundipharma.

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program.

Invasive candidiasis is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more. It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays. Over the last 15 years, there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options.

Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU. Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.