Promising treatment targeting 40% mortality Candida infection
pharmafile | March 4, 2022 | News story | Medical Communications |
A Promising Innovation Medicine (PIM) designation has been awarded to rezafungin by the MHRA, for the treatment of invasive candidiasis. This development aims to address the mortality rate of 40% among patients with invasive candidiasis, in spite of available treatments.
Rezafungin is a next-generation once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. Echinocandins are a kind of antifungal drug.
A PIM designation gives an early indication that the drug may be eligible for the Early Access to Medicines Scheme in the UK, which allows the use of medicines not yet approved by the relevant regulatory authorities.
For the MHRA to grant a PIM designation, medicinal products must treat a condition which is 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. Products must also be likely to offer a major advantage over methods currently used in the UK. Finally, the potential adverse effects of the medicinal product must be likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.
Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream, or deep/visceral tissues. It 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%
Brian Sheehan, PhD, Chief Scientific Officer at Mundipharma, shared: “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.”
“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,” commented Taylor Sandison, M.D., Chief Medical Officer at Cidara.
Ana Ovey
