Astellas leukaemia therapy receives EU orphan drug designation

Pharmaceutical Company Product News

Astellas has received orphan drug designation from the European Commission for gilteritinib, its promising new therapy for acute myeloid leukaemia.

The European Medicines Agency's Committee for Orphan Medicinal Products recommended this designation due to the potential benefits this medicine can offer to patients suffering a rare condition that affects no more than five in 10,000 people.

“Astellas' new cancer drug gilteritinib has been granted orphan drug designation by the European Medicines Agency.“

Gilteritinib is an investigational compound that has demonstrated inhibitory activity against two common types of FLT3 mutations seen in approximately one-third of patients with this form of cancer.

Acute myeloid leukaemia impacts the blood and bone marrow, with its incidence increasing with age. In western Europe, it is estimated that there are around 13,000 new cases of the disease every year.

Dr Steven Benner, senior vice-president and global therapeutic area head of oncology development at Astellas, said: "We are grateful to the European Medicines Agency for acknowledging the unique needs of patients with rare diseases, and for providing a potential path forward for gilteritinib in supporting these patients."

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