EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat one of the neglected tropical diseases, schistosomiasis, in preschool-aged children (3 months to 6 years of age) on December 15. EMA assessed arpraziquantel under the EU-Medicines for all (EU-M4all) *1 procedure for high-priority medicines intended for use in countries outside the European Union. For more details on arpraziquantel, please refer to the Consortium’s press release.

Astellas provided its innovative formulation technology to co-develop arpraziquantel as a member of the Consortium. The new pediatric formulation of arpraziquantel is palatable for very young children by reducing the bitter taste associated with the medication and administered via a 150 mg dispersible tablet that is dissolved in water. The prototype of the pediatric formulation has been developed by Astellas and further optimized by Merck (Germany) for global production using simple manufacturing processes yielding tablets that can remain shelf stable, even in hot and humid tropical climates. Farmanguinhos (Brazil) brings expertise in production and distribution and will be the manufacturing site for the future introduction of the new pediatric medication in endemic countries. The partnership with Universal Corporation Ltd. (Kenya) is also supporting the planned future large-scale local production to serve African countries.

In parallel with this regulatory work, the Consortium’s implementation research program (ADOPT)*2 is ongoing and preparing for the introduction of arpraziquantel in the first endemic countries in Africa. To ensure equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established. The intent is to make the product available at an at-cost basis in sub-Saharan African countries.

Astellas has set a Strategic Goal to “deepen our engagement in sustainability” in the Astellas Corporate Strategic Plan 2021. To address the key sustainability issue of Access to Health (ATH), Astellas uses a comprehensive approach including, (1) Astellas’ core business (Rx, Rx+), (2) Enhancing availability of Astellas products (Access to Medicines), and (3) Collaboration and support for the activities implemented by external partners. Initiatives in the Consortium apply to (3), and the positive CHMP scientific opinion by EMA of arpraziquantel represents a significant milestone in alignment with Astellas’ Access to Health focus.

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