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FDA designates isavuconazole QIDP drug
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Astellas recently announced that the FDA has designated its antifungal agent isavuconazole as a qualified infectious disease product, or QIDP, for the treatment of invasive candidiasis.
Under the 2012 Generating Antibiotic Incentives Now (GAIN) Act, QIDP status makes the drug eligible for priority review and gives Astellas a 5-year extension of market exclusivity in the United States if the drug is approved by the FDA.
The FDA already has given a QIDP designation to isavuconazole for invasive aspergillosis and invasive mucormycosis.
“The need to treat serious fungal infections can be one of life or death,” Bernie Zeiher, executive vice president of global development and therapeutic area head of infectious disease at Astellas, said in a press release. “This QIDP designation, along with the previous two we have received, emphasizes how important it is to patients and their families that products are available to treat these infections.”
Isavuconazole is an investigational, once-daily intravenous and oral broad-spectrum antifungal agent. The drug has demonstrated in vitro and in vivo activity against a wide range of yeasts, including Candida species, and molds such as Aspergillus species and those that cause mucormycosis.
In a phase 3 study of invasive aspergillosis, isavuconazole was noninferior to voriconazole on the primary endpoint of all-cause mortality at day 42. Additionally, there were statistically fewer adverse events associated with the drug vs. voriconazole in the System Organ Classes of hepatobiliary, skin and eye disorders. The most common adverse events in both groups included nausea, vomiting, pyrexia and diarrhea, according to Astellas.
Astellas is co-developing isavuconazole with Basilea Pharmaceutica International Ltd.