The Medicines and Healthcare products Regulatory Agency (MHRA)
has today approved the medicine Rezzayo (rezafungin) to treat a
fungal infection called invasive candidiasis.
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.
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.
We’re 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 body’s 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.
