Basilea Pharmaceutica Ltd. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of isavuconazole for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is inappropriate. Invasive aspergillosis and mucormycosis are life-threatening fungal infections predominantly occurring in cancer and other immuno­compromised patients. Isavuconazole will be marketed under the trade name of Cresemba if approved in the European Union.

"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. 

The European Commission (EC) will now review the CHMP's positive opinion for isavuconazole. The EC generally follows CHMP recommendations. If approved by the EC, the marketing authorization for isavuconazole will be valid in all 28 European Union member states, as well as in Iceland, Liechtenstein and Norway.

For more details, go to: http://www.basilea.com/News-and-Media/Basilea-announces-that-CHMP-recommends-approval-of-isavuconazole-CRESEMBA-as-a-treatment-for-invasive-aspergillosis-and-mucormycosis-in-the-European-Union/c01a300d-fe10-06a1-6b5c-de29e60fe0ec