FDA Grants Infectious Disease Designation to Invasive Candidiasis Drug

A new drug has been designated a Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration (FDA) to treat patients diagnosed with invasive candidiasis.

According to a statement from Astellas, the drug’s manufacturer, isavuconazole received the QIDP designation for what the company describes as “a life-threatening, invasive fungal infection.”

With the designation, the medication “receives a priority review and a 5-year extension of market exclusivity in the United States,” according to the statement. Isavuconazole previously received similar designations for invasive aspergillosis and invasive mucormycosis.

Isavuconazole is a once-daily intravenous and oral broad-spectrum antifungal medication. Adverse events that occurred during its phase 3 invasive aspergillosis study included nausea, vomiting, fever, and diarrhea, which the company described as being “statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary, skin, and eye disorders.”

Bernie Zeiher, Executive Vice President of Global Development and Therapeutic Area Head of Infectious Disease for Astellas, said the designation is another step towards getting patients with the condition the help they need.

“The need to treat serious fungal infections can be one of life or death,” he noted. “The QIDP designation, along with the previous 2 we have received, emphasizes how important it is to patients and their families that products are available to treat these infections.”

The medication is being co-developed by Basilea Pharmaceutica International, Ltd.