Mundipharma and Cidara Therapeutics receive positive CHMP opinion forrezafungin for the treatment of Invasive Candidiasis in adults
October 17, 2023 – Biotechnology – CHMP, Cidara, EMA, Mundipharma, candidiasis
- The opinion was based on positive results from the pivotal ReSTORE phase 3 clinical
trial and supported by the STRIVE phase 2 clinical trials and extensive nonclinical
development programme - If approved by the European Medicines Agency (EMA), rezafungin could be the first new
treatment option in over 10 years for patients with invasive candidiasis.
13 October 2023 — Cambridge, UK and California, US — Mundipharma and Cidara
Therapeutics today announced that the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for
rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.
The CHMP based its positive opinion on results from the pivotal ReSTORE phase 3 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 2 clinical trials and extensive nonclinical development
programme. 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 3
ReSTORE trial, said, “This positive opinion is welcome news for patients who suffer from
invasive candidiasis in the European Union (EU) 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, PhD,
chief scientific officer at Mundipharma.
“Following the FDA approval of rezafungin in the US 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 EU,” said Taylor
Sandison, MD MPH, 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 Cidara Therapeutics
Cidara is using its proprietary Cloudbreak platform to develop novel drug-Fc conjugates
(DFCs). These targeted immunotherapies offer the unique opportunity to create “single
molecule cocktails” comprised of targeted small molecules and peptides coupled to a human
antibody fragment (Fc). DFCs are designed to save lives and improve the standard-of-care for
patients facing cancers and other serious diseases by inhibiting specific disease targets while
simultaneously engaging the immune system. In addition, Cidara received FDA approval for
REZZAYO (rezafungin for injection), which it has licensed to multiple partners to
commercialise in the US and ex-US. Cidara is headquartered in San Diego, California, US. For
more information, please visit www.cidara.com.
About Mundipharma
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific,
Canada, Europe, Latin America and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease and consumer healthcare as well as other severe and debilitating disease areas. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.
