MHRA Awards Promising Innovation Medicine Designation for the Treatment of Invasive Candidiasis

Mundipharma and Cidara Therapeutics announced on March 3, 2022 that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Promising Innovative Medicine (PIM) designation to rezafungin for treatment of invasive candidiasis.

A PIM designation is a prerequisite for the UK’s Early Access to Medicines Scheme (EAMS), which permits the use of medicines not yet approved by the relevant regulatory authorities. A condition must be life-threatening or seriously debilitating, with little to no treatment method or prevention, in order to be granted a PIM designation.

Invasive candidiasis is a life-threatening systemic Candida infection of the bloodstream or deep tissues. There is a significant unmet need for successful treatment options for invasive candidiasis; the mortality rate for patients with the infection is as high as 40%.

Rezafungin is being developed for both the prevention and treatment of invasive candidiasis and other serious fungal infections. Cidara Therapeutics is conducting clinical trials of the treatment and is partnering with Mundipharma, which has commercial rights to rezafungin outside the United States and Japan.

“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,” commented Brian Sheehan, PhD, chief scientific officer of Mundipharma, in a press release. “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.”

Source: Cidara