CHMP recommends approval of isavuconazole in the EU

Basilea has announced that the CHMP adopted a positive opinion recommending the approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis for whom amphotericin B is inappropriate.

Invasive aspergillosis and mucormycosis are life-threatening fungal infections predominantly occurring in cancer and other immunocompromised patients.

“Today’s positive CHMP opinion is a major step forward in making isavuconazole available in Europe for patients suffering from serious invasive fungal infections. Invasive aspergillosis and mucormycosis are life-threatening infections predominantly affecting cancer and other immunocompromised patients and are associated with high morbidity and mortality. We are committed to bring innovative treatments to patients with high medical need and look forward to the European Commission’s decision in the coming months,” said Ronald Scott, Basilea’s Chief Executive Officer.

Commenting on the CHMP’s opinion, Professor Johan A. Maertens, Department of Haematology, University Hospital Gasthuisberg, Belgium has highlighted the urgent need for new drugs in treating patients with invasive fungal infections, stating that, “morbidity and mortality associated with invasive fungal infections remain unacceptably high. Isavuconazole has shown promising results in the treatment of invasive mould infections and, if approved, has the potential to offer a new treatment option to patients suffering from these serious conditions.”

The European Commission (EC) will now review the CHMP’s positive opinion for isavuconazole.

Positive CHMP opinion bases on results from two Phase 3 clinical studies of isavuconazole

The positive CHMP opinion is based on results from the isavuconazole development programme. The safety and efficacy profile of isavuconazole in adult patients with invasive aspergillosis was demonstrated based on data from two phase 3 clinical studies: SECURE, a randomised, double-blind, active-control study in 516 patients with invasive aspergillosis, and VITAL, an open-label non-comparative 146-patient study of isavuconazole in renally impaired patients with invasive aspergillosis, or in patients with invasive fungal disease caused by other emerging fungi.

In the SECURE study, isavuconazole was non-inferior to voriconazole based on the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat population.

The safety and efficacy profile of isavuconazole in patients with mucormycosis was demonstrated based on data from the VITAL study, which included a subpopulation of 37 patients with mucormycosis. All-cause mortality at Day 42 was 38% which is similar to mortality rates reported in literature for the treatment of mucormycosis. The efficacy of isavuconazole for the treatment of mucormycosis has not been evaluated in concurrent, controlled clinical trials.