Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company focused on developing life-saving therapies, announced a significant breakthrough with the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) approving REZZAYO (rezafungin acetate) for invasive candidiasis treatment in adults. This announcement is a major advancement in healthcare, addressing a critical need for new treatments in this field.

Taylor Sandison, Chief Medical Officer at Cidara, expressed enthusiasm about the approval: “Our team, in partnership with Mundipharma, is proud to help bring the first new treatment option in 15 years to patients with this disease.”

This MHRA approval follows the positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority of weekly-dosed rezafungin compared to daily-dosed caspofungin, the standard of care. Rezafungin’s efficacy and safety are supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. The U.S. Food and Drug Administration (FDA) and the European Commission (EC) had previously approved rezafungin.

In a significant partnership, Cidara Therapeutics has collaborated with Mundipharma, granting it commercial rights to rezafungin outside the U.S. and Japan. This partnership has proven fruitful, with Cidara entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval. Furthermore, Cidara announced REZZAYO’s approval in the European Union (EU) for treating invasive candidiasis in adults, following the positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Invasive candidiasis, a severe, life-threatening infection, affects critically ill individuals, particularly those with weakened immune systems. With mortality rates up to 40% and a significant burden on healthcare systems, there has been a pressing need for new treatments. The approval of REZZAYO is a substantial development in addressing this unmet medical need.

Professor Oliver Cornely, a key figure in the ReSTORE trial, emphasized the global necessity for new treatments: “Today’s announcement by the European Commission marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option.“

With the EU approval, Cidara is set to receive an approximate $11.14 million milestone payment from Mundipharma. Under their Collaboration and License Agreement, additional potential payments of up to approximately $470 million are anticipated upon achieving development and regulatory milestones, alongside double-digit royalties on annual net sales.

Cidara Therapeutics’ REZZAYO approval in the UK and EU marks a significant milestone in the fight against invasive candidiasis. This approval not only provides a new treatment option for a disease with high mortality rates but also exemplifies the successful collaboration between biotech companies and regulatory agencies in bringing innovative therapies to market. REZZAYO’s approval could lead to a paradigm shift in how invasive candidiasis is treated, potentially improving patient outcomes and reducing healthcare burdens.

  Cidara Therapeutics, European Union, invasive candidiasis, Mundipharma, Oliver Cornely, rezafungin acetate, REZZAYO, Taylor Sandison, UK MHRA, United Kingdom