New antifungal drug approved by FDA

March 6, 2015

Cresemba (isavuconazonium sulfate, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.

Isavuconazonium sulfate (Cresemba, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.

The fungal infection, aspergillosis, is caused by Aspergillus species. Invasive mucormycosis is caused by Mucorales fungi. Studies have shown that this newly approved antifungal agent is a safe and effective treatment option for both of these serious fungal infections.

FDA based its approval for the new antifungal drug to treat invasive aspergillosis on findings from a clinical trial including 516 study patients who were randomly assigned to treatment with either isavuconazonium sulfate or another approved agent for invasive aspergillosis, voriconazole. Another clinical trial, a single-arm study, including 37 patients given isavuconazonium sulfate and then compared with the natural disease progression seen with untreated mucormycosis served as the basis for the drug’s FDA approval as treatment for this other fungal infection.

FDA has granted the new antifungal agent orphan drug status for invasive aspergillosis and invasive mucormycosis because these infections are so rare.

Isavuconazonium sulfate is also the sixth approved antifungal or antibacterial drug product that has been designated as a Qualified Infectious Disease Product (QIDP), giving it priority review status with the agency. QIDP is a designation given to those products that are used for the treatment of serious or life-threatening infections under the FDA Safety and Innovation Act, as part of the title Generating Antibiotic Incentives Now (GAIN). QIDP designation also means that the drug will have an additional 5 years of marketing exclusivity.

The new antifungal medication, available in both oral and intravenous formulations, is part of the drug class known as azole antifungal agents. These drugs target the cell wall of a fungus.