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Basilea Pharmaceutica Announces Approval of Isavuconazole in Europe

Strategic Insights

— 2 min read

The European Commission has approved isavuconazole for the treatment of adult patients with invasive aspergillosis and mucormycosis, two life-threatening fungal infections often occurring in patients with cancer and other immunocompromised individuals. This approval marks a significant milestone for Basilea Pharmaceutica, as it allows the company to launch isavuconazole in major European countries. Isavuconazole will be marketed under the trade name CRESEMBA. The approval is based on data from two phase 3 clinical studies, SECURE and VITAL, which demonstrated the safety and efficacy of isavuconazole in treating invasive aspergillosis and mucormycosis.

Ronald Scott, Basilea's Chief Executive Officer, stated that the European approval of CRESEMBA is a key milestone for the company, offering a new therapeutic option for patients suffering from these life-threatening fungal infections. The approval also provides a unique opportunity to launch CRESEMBA as the company's second hospital anti-infective in Europe, offering a significant commercial synergy with the company's other product, Zevtera.

Key Takeaways:

  • The European Commission has approved isavuconazole for the treatment of adult patients with invasive aspergillosis and mucormycosis.
  • The approval is based on data from two phase 3 clinical studies, SECURE and VITAL, which demonstrated the safety and efficacy of isavuconazole.
  • Isavuconazole will be marketed under the trade name CRESEMBA in Europe.
  • The approval provides a unique opportunity for Basilea Pharmaceutica to launch CRESEMBA as the company's second hospital anti-infective in Europe.
  • The product will be launched in major European countries, providing a significant commercial synergy with the company's other product, Zevtera.
  • The SECURE study demonstrated that isavuconazole was non-inferior to voriconazole in the treatment of invasive aspergillosis, with all-cause mortality at Day 42 being 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole treatment group.
  • The VITAL study demonstrated that isavuconazole was effective in treating mucormycosis, with an overall response against mucormycosis at the end of therapy being 31%.

Statistics:

  • 516 patients participated in the SECURE study.
  • 146 patients participated in the VITAL study.
  • The most frequent adverse events for patients treated with isavuconazole in clinical phase 3 studies were nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (17%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%).
  • Isavuconazole is an intravenous and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate.
  • Basilea Pharmaceutica holds full rights to commercialize isavuconazole in markets outside the United States.

Sources:

  • Press release: "Basilea Pharmaceutica Ltd. Announces Approval of Isavuconazole (CRESEMBA) by the European Commission for the Treatment of Invasive Aspergillosis and Mucormycosis" (http://hugin.info/134390/R/1959420/714149.pdf)
  • European Congess of Clinical Microbiology and Infectious Diseases (ECCMID) 2015: A comparison of the safety profiles of isavuconazole vs voriconazole in the phase 3 SECURE study in patients with invasive mould infections (https://www.escmid.org/escmid_library/online_lecture_library/material/?mid=20850)
  • GlobeNewswire, "Basilea Pharmaceutica Ltd. Announces Approval of Isavuconazole (CRESEMBA) by the European Commission for the Treatment of Invasive Aspergillosis and Mucormycosis" (http://www.globenewswire.com/newsroom/ti?nf=MTMjMTAxNTI3MzQjMjc5MjE=)

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