FDA Approves New Antifungal Drug from Astellas

Astellas Pharma will launch its antifungal drug Cresemba in the coming months, following FDA approval for adults with invasive aspergillosis and invasive mucormycosis — rare, but serious fungal infections most often seen in patients with compromised immune systems.

Although there are multiple drugs approved to treat aspergillosis and one for mucormycosis, mortality rates remain high, says Astellas spokeswoman Marjorie Moeling. Roughly 30 percent of patients with invasive aspergillosis die, while 44 percent to 96 percent succumb to mucormycosis, she said.

By contrast, in clinical trials, Cresemba (isavuconazonium sulfate) cut all-cause mortality from aspergillosis and mucormycosis to 18.6 percent and 38 percent, respectively.

Astellas’ drug is the sixth qualified infectious disease product, or QIDP, to see approval under the provisions of the 2012 Generating Antibiotic Incentives Now Act, which aims to combat growing levels of resistance to anti-infective drugs and incentivize drugmakers to bolster slowing pipelines.

As a QIDP, Cresemba received priority review and five years of extra marketing exclusivity. The drug was also granted orphan drug designation, which comes with seven years additional exclusivity, giving Cresemba 12 added years in all. — Lena Freund