Basilea reports topline results of isavuconazole phase 3 study in candidemia and other invasive Candida infections - Seite 2

The key secondary endpoint of overall treatment response at two weeks after the end of treatment was 54.8% in the isavuconazole treatment group and 57.2% in the caspofungin/vori­conazole treatment group with an adjusted treatment difference of -2.7% (95% CI; -12.2%, 6.8%).

About the ACTIVE study

ACTIVE is a phase 3, double-blind, randomized study of 440 adult patients (ITT population)* with candidemia and other invasive Candida infections at multiple sites globally. The primary endpoint of the study was to compare the overall treatment response of isavuconazole versus caspofungin at the end of i.v. therapy as determined by the independent, blinded Data Review Committee (DRC). After study day 10, patients had the option to continue i.v. therapy or switch to oral therapy. The key secondary endpoint was to assess the success rate of overall treatment response at the first follow-up visit (two weeks after the end of therapy) for i.v./oral isavuconazole-treatment versus the comparator regimen of caspofungin i.v. or caspofungin i.v. followed by oral voriconazole.¹

About invasive Candida infections

Invasive infections by Candida yeasts are associated with high morbidity and mortality. Estimates of the attributable mortality of Candida bloodstream infections (candidemia) range from 15% to 49%.^{2, 3, 4}

About isavuconazole

Isavuconazole is an azole antifungal and the active agent of the prodrug isavuconazonium sulfate, which is indicated in the U.S. for use in the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. Basilea is co-developing the drug with Astellas Pharma Inc., who is marketing the drug in the United States. Outside the U.S., isavuconazole is an investigational product and currently not approved for commercial use.

Isavuconazole was designated a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis, mucormycosis and candidiasis under the U.S. Generating Antibiotics Incentives Now (GAIN) Act. It has European Union orphan drug status for the treatment of invasive aspergillosis and mucormycosis.

On July 23, 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of isavuconazole for adults as treatment for invasive aspergillosis, and for the treatment of patients with invasive mucormycosis for whom amphotericin B is inappropriate.