Basilea/Pfizer’s Antifungal Cresemba (Isavuconazole) Receives NMPA Acceptance for Review in China for Invasive Aspergillosis

November 28, 2020 /Bio ValleyBIOON/ -- Basilea Pharmaceutica Ltd. is a Swiss-headquartered multinational pharmaceutical company dedicated to developing solutions that addressTumorpharmaceutical products in the field of anti-infective therapy. Recently, the company announced that its partnerPfizerPfizer’s Marketing Authorization Application (MAA) for the antifungal drug isavuconazole (Cresemba®) for the treatment of invasive aspergillosis in adults has been accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). In August, Basilea announced that its MAA for Cresemba for the treatment of mucormycosis had also been accepted for review by the NMPA.

Isavuconazole (isavuconazole) is an intravenous (IV) and oral azole antifungal agent marketed under the brand name Cresemba. Isavuconazole has been approved in the 27 European Union member states, as well as in Iceland, Liechtenstein, Norway, and the United Kingdom: (1) for the treatment of invasive aspergillosis in adults; (2) for the treatment of mucormycosis in adults for whom amphotericin B is unsuitable.

David Veitch, CEO of Basilea, stated, “Invasive aspergillosis and mucormycosis are the two most common forms of invasive mold infections and represent significant causes of morbidity and mortality in patients with hematologic malignancies following intensive chemotherapy. China is a commercially critical market for Cresemba, accounting for more than 15% of the global market for novel antifungal agents. Therefore, we are highly pleased with Pfizer’s progress in China. The acceptance by the National Medical Products Administration (NMPA) of the marketing authorization application for isavuconazole for review marks an important milestone in bringing this product to the Chinese market and addressing the unmet medical needs of patients with invasive mold infections.”

In November 2017, Basilea and Pfizer expanded their existing licensing agreement for Europe (excluding the Nordic countries), Russia, Turkey, and Israel to include China (including Hong Kong and Macau) and 16 countries in the Asia-Pacific region. Under the agreement with Pfizer, Basilea is eligible to receive up to approximately $630 million in regulatory and sales milestone payments, in addition to sales-based royalties.

Cresemba has also been approved in the United States and other European countries. In the United States, Europe, and Australia, Cresemba has received Orphan Drug Designation (ODD) for its approved indications. Basilea has entered into several licensing and distribution agreements for isavuconazole, covering the United States, Europe, China, Japan, Latin America, the Asia-Pacific region, the Middle East and North Africa, Canada, Russia, Turkey, and Israel.(Bio Valley Bioon.com)

Original Source: Basilea Reports Acceptance for Regulatory Review of Pfizer’s Marketing Authorizationapplication for antifungal isavuconazole (Cresemba®) in invasive aspergillosis in China