Mundipharma and Cidara Therapeutics, Inc. have announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis.
Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.
For the MHRA to grant a PIM designation, medicinal products must meet the following criteria:
- The condition should be life-threatening or seriously debilitating with a high unmet need for which there is no method of treatment, diagnosis or prevention available or where existing methods have serious limitations.
- The medicinal product is likely to offer major advantage over methods currently used in the UK.
- The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.
A PIM designation is a pre-requisite for application to the UK’s Early Access to Medicines Scheme (EAMS). This scheme aims to give patients with life threatening or seriously debilitating conditions such as invasive candidiasis, access to medicines that do not yet have a marketing authorisation. Mundipharma and Cidara plan to submit an EAMS application for rezafungin in Q3 2022.
Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma, said: “Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high, demonstrating that there is still a clear unmet need for new treatment options to address this serious disease.
“Rezafungin, as a next generation echinocandin, has the potential to help critically ill, vulnerable patients battling invasive Candida infections. We would like to thank the MHRA for this recognition and look forward to working closely with them to ensure that patients in the UK can benefit from rezafungin.”
“This PIM designation for once-weekly rezafungin is indicative of the potential that this product may have in helping patients to fight deadly Candida infections,” said Taylor Sandison, M.D., Chief Medical Officer at Cidara.
Cidara has partnered with Mundipharma who has commercial rights to rezafungin outside the U.S. and Japan.
