Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults

Our Bureau

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults.

“Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said Taylor Sandison, M.D. M.P.H., Chief Medical Officer at Cidara. “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 approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the United States Food and Drug Administration (FDA) and European Commission (EC).

Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. The company is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval.

Author

Leave a Reply

Your email address will not be published. Required fields are marked *

Next Post

Venus Remedies gets coveted GMP certification from Libya

Venus Remedies, a globally recognised pharmaceutical company, has been awarded the Good Manufacturing Practices (GMP) certification for its facilities from the Ministry of Health, Libya. This accomplishment is a testament to the company’s commitment to quality, safety and efficiency in the production of injectable pharmaceuticals, including oncology, antibiotic and anticoagulant […]
"Venus Remedies GMP Certification"

Subscribe Now