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Rezafungin approvals continue as MHRA gives go ahead for use in invasive candidiasis

Rezafungin (brand name Rezzayo) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of invasive candidiasis in adults.

This follows its approval by the European Commission in late December 2023 for the same indication.

An antimycotic, rezafungin selectively inhibits the fungal enzyme 1,3-β-D-glucan synthase, inhibiting formation of 1,3-β-D-glucan, an essential component of the fungal cell wall. This, in turn, results in rapid and concentration-dependent fungicidal activity in Candida species.

Rezafungin 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.

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.

‘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.’

Rezafungin demonstrates non-inferiority

The MHRA marketing authorisation was given to Napp Pharmaceuticals and is based on results from the randomised, double-blind, controlled phase 3 ReSTORE clinical trial.

This compared the efficacy and safety of intravenous rezafungin with intravenous caspofungin – the current standard of care – in patients with candidaemia and invasive candidiasis.

Chosen at random, 93 of the patients with invasive candidiasis were given a weekly dose of rezafungin and the other 94 were given a daily dose of caspofungin, for between two to four weeks. 

A total of 55 of the patients on rezafungin were cured at day 14, and 57 patients on caspofungin. Some 22 patients had died from any cause by day 30 on rezafungin, compared with 20 on caspofungin.

The trial therefore demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to caspofungin dosed once daily.

The most common side effects of rezafungin, which may affect more than 1 in 10 people, include hypokalaemia, diarrhoea and pyrexia.