The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Mundipharma and Cidara Therapeutics’ rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.
The CHMP based its positive opinion 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. This finding was supported by the STRIVE Phase II clinical trials and extensive nonclinical development program. The ReSTORE trial provides evidence of the efficacy and safety of rezafungin as a potential new treatment option for invasive candidiasis with a once-weekly dosing schedule.
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 where the mortality rate can be 40% or more. There is a clear need for alternative options to treat this disease, particularly as there have been no new treatment options over the last decade.
Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said: “This positive opinion is welcome news for patients who suffer from invasive candidiasis in the European Union where the mortality rate for patients with invasive candidiasis remains high. A new treatment option for these serious infections is a much-needed addition.”
“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.