FDA News

FDA grants QIDP and fast track status to Cidara’s rezafungin prophylaxis program

Jeff Stein, PhD
Jeffrey Stein

Cidara Therapeutics announced that its prophylaxis development program for IV rezafungin — the company’s lead antifungal candidate — has received both fast track and qualified infectious disease product designations from the FDA.

“Rezafungin is being developed for two indications: one for the treatment of candidemia and invasive candidiasis and this one that was just announced today, is for the prevention of fungal infections in patients undergoing bone marrow transplants,” Cidara President and CEO Jeffrey Stein, PhD, told Infectious Disease News. “It’s important that the FDA recognizes that this is a significant unmet need.”

Previously, rezafungin received a qualified infectious disease product (QIDP) designation for the treatment of invasive fungal infections caused by Candida. The newest rezafungin QIDP designation will allow Cidara to develop the antifungal for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation.

According to a news release, rezafungin is a novel antifungal echinocandin that is being developed as a once-weekly, high-exposure therapy. It is being studied to address current unmet treatment needs in patients with candidemia and invasive candidiasis and as prophylaxis for invasive fungal infections caused by common fungal pathogens such as Candida, Aspergillus and Pneumocystis, the company said.

Currently, there is no approved agent that can prevent infections caused by all three of these pathogens, and multiple antifungal drugs are required for prophylaxis regimens due to safety and tolerability concerns, according to the release.

Cidara said it will begin the phase 3 ReSPECT prophylaxis clinical trial of rezafungin in allogeneic bone marrow transplant patients in the first quarter of 2019.

If rezafungin is approved by the FDA, it will be eligible for an additional 5 years of marketing exclusivity because the QIDP designation was provided under the Generating Antibiotic Incentives Now Act.

“The fact that we now have fast track designation enables us to have more frequent interactions with the FDA to expedite the development and getting priority review pulls up the review of our [new drug application] from the usual 10 months, now to a 6-month review period,” Stein said. “This is all very important to get this new medicine to patients in need.”  – by Marley Ghizzone

Disclosure: Stein is CEO of Cidara Therapeutics.

Jeff Stein, PhD
Jeffrey Stein

Cidara Therapeutics announced that its prophylaxis development program for IV rezafungin — the company’s lead antifungal candidate — has received both fast track and qualified infectious disease product designations from the FDA.

“Rezafungin is being developed for two indications: one for the treatment of candidemia and invasive candidiasis and this one that was just announced today, is for the prevention of fungal infections in patients undergoing bone marrow transplants,” Cidara President and CEO Jeffrey Stein, PhD, told Infectious Disease News. “It’s important that the FDA recognizes that this is a significant unmet need.”

Previously, rezafungin received a qualified infectious disease product (QIDP) designation for the treatment of invasive fungal infections caused by Candida. The newest rezafungin QIDP designation will allow Cidara to develop the antifungal for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation.

According to a news release, rezafungin is a novel antifungal echinocandin that is being developed as a once-weekly, high-exposure therapy. It is being studied to address current unmet treatment needs in patients with candidemia and invasive candidiasis and as prophylaxis for invasive fungal infections caused by common fungal pathogens such as Candida, Aspergillus and Pneumocystis, the company said.

Currently, there is no approved agent that can prevent infections caused by all three of these pathogens, and multiple antifungal drugs are required for prophylaxis regimens due to safety and tolerability concerns, according to the release.

Cidara said it will begin the phase 3 ReSPECT prophylaxis clinical trial of rezafungin in allogeneic bone marrow transplant patients in the first quarter of 2019.

If rezafungin is approved by the FDA, it will be eligible for an additional 5 years of marketing exclusivity because the QIDP designation was provided under the Generating Antibiotic Incentives Now Act.

“The fact that we now have fast track designation enables us to have more frequent interactions with the FDA to expedite the development and getting priority review pulls up the review of our [new drug application] from the usual 10 months, now to a 6-month review period,” Stein said. “This is all very important to get this new medicine to patients in need.”  – by Marley Ghizzone

Disclosure: Stein is CEO of Cidara Therapeutics.