Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1) - Seite 2

“We would like to thank the CHMP for their careful consideration of the use of rezafungin. This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive Candida infections, giving hope to patients battling this infection and their families,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma.

“Following the FDA approval of rezafungin in the United States earlier this year, the positive CHMP opinion reinforces the benefit of rezafungin and marks an important milestone in our drive to help patients with deadly Candida infections in the European Union,” said Taylor Sandison, M.D., M.P.H, Chief Medical Officer at Cidara.

The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasis in adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

About invasive candidiasis

Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. ^7,8 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.¹⁰

About rezafungin

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. Cidara has completed a Phase III clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).¹¹

In this ReSTORE trial, rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorisation Application (MAA) submission of global cure at Day 14. Both results demonstrated statistical non-inferiority of rezafungin dosed once-weekly versus caspofungin dosed once-daily, the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.²