The European Medicines Agency (EMA) has accepted marketing authorisation applications for Hansa’s Idefirix (imlifidase) and Astellas' Xospata (gilteritinib).
Xospata has been accepted for regulatory review for the treatment of adults who have relapsed or refractory FLT3-mutated acute myeloid leukaemia (AML), while Idefirix will be considered as a means of enabling kidney transplantation in highly sensitised patients.
The acceptance of Idefirix follows Hansa’s submission of the Marketing Authorisation Application (MAA) on 5 February 2019 and marks the beginning of the regulatory review process for the drug in the European Union (EU), and the application for Xospata is based on data from the Phase IIIADMIRAL trial investigating the drug for the treatment of adult patients with FLT3mut+ relapsed or refractory AML.
“The MAA filing represents a significant milestone for Hansa as it is our first regulatory application for marketing authorisation and a major step toward making Idefirix available for highly sensitised patients waiting for a kidney transplant. These patients have a significant unmet medical need, often remaining in a debilitating disease state on long-term dialysis treatment.
We have demonstrated that our unique enzyme’s rapid and specific cleavage of IgG antibodies successfully enables lifesaving kidney transplantation, for these patients. Idefirix has the potential to significantly improve highly sensitised patients’ access to kidney transplantation,” said Søren Tulstrup, chief executive of Hansa.