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EMA accept marketing authorisation application for invasive candidiasis treatment

Published on 22/08/22 at 10:45am

The EMA has accepted the marketing authorisation application (MAA) for rezafungin, for the treatment of invasive candidiasis in adult patients. Invasive candidiasis is a severe, life-threatening Candida infection of the bloodstream or deep tissues.

The MAA is based on results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once weekly when compared to the current standard-of-care, capsofungin, dosed once daily.

Despite existing treatments for invasive candidiasis which are currently available, the mortality rate for patients with the infection remains high, at up to 40%. There is therefore a significant medical need for new treatment options in order to address the disease.

There has been no significant progress in treatment for invasive candidiasis treatment over the last decade.

“Rezafungin, as a next generation echinocandin, represents the first advancement in the treatment of invasive Candida infections in a very long time. If approved, the treatment could bring new hope for critically ill, vulnerable patients battling with this deadly disease in the EU,“ said Brian Sheehan, PhD, Chief Scientific Officer at Mundipharma. “We are pleased that the EMA has accepted our marketing authorisation application for rezafungin, and we look forward to working with the EMA to bring this medicine to patients.”

The infection continues to be an area of significant unmet need, particularly for critically ill patients in hospitals, and patients with compromised immune system. Invasive candidiasis is an infection caused by a yeast called Candida. It is a more serious infection than other Candida infections of the mouth and throat, and can affect the blood, heart, eyes, bones, and other parts of the body.

Rezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US.  A New Drug Application was recently submitted to the US Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis the USA. The FDA has previously identified rezafungin as a Qualified Infectious Disease Product (QIDP), which grants both Fast Track and Priority Review status. 

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