Medicines Healthcare Products Regulatory Agency
Invasive candidiasis is an infection caused by a yeast called Candida. While some common Candida infections (such as thrush) are easily treatable and do not pose a serious risk to health, invasive candidiasis is a severe infection that can affect the blood, heart, brain, eyes and bones and other parts of the body.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
Were assured that the appropriate regulatory standards for the approval of this medicine have been met.
As with all products, we will keep its safety under close review.
The treatment is administered once a week by a drip into the vein until at least 14 days after the last day Candida is found in the bloodstream.
The active ingredient in Rezzayo, rezafungin, is an antifungal that blocks the action of the enzyme needed by fungal cells to make a molecule that strengthens their cell walls. This means the fungal cells become fragile and stops the fungus growing and spreading. It gives the bodys natural defences a chance to remove the infection.
This approval is supported by evidence from a randomised, double-blind, controlled phase 3 clinical trial involving 187 patients with invasive candidiasis.
Chosen at random, 93 of the patients were given a weekly dose of rezafungin and the other 94 were given a daily dose of caspofungin (another antifungal treatment), for between 2 to 4 weeks.
55 of the patients on rezafungin were cured at day 14, against 57 patients on caspofungin, and 22 patients had died (from any cause) by day 30 on rezafungin, against 20 on caspofungin.
The most common side effects of the medicine(which may affect more than 1 in 10 people) include low blood potassium levels (hypokalaemia), diarrhoea and fever.
As with any medicine, the MHRA will keep the safety and effectiveness of Rezzayo under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors?
- The new marketing authorisation was granted on 29 January 2024 to Napp Pharmaceuticals Ltd
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- This was a randomised, double-blind clinical trial, where neither the participants nor the staff on the trial were aware of what each participant was taking. For more information about the studies, see the Summary of Product Characteristics.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call