EMA accepts Deciphera’s filing for vimseltinib

Japanese drugmaker Ono Pharmaceutical (TYO: 4528) announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib, a colony stimulating factor 1 receptor (CSF1R), for the treatment of patients with tenosynovial giant cell tumor (TGCT),].

The drug is under development by Deciphera Pharmaceuticals, which Ono recently acquired in a deal worth around $2.4 billion. The deal also included Qinlock (ripretinib), which had global sales of $163 million in 2023. Ono Pharma has previously said it expects Qinlock and vimseltinib together will reach peak global sales of $1 billion.

The review of the MAA begins under the EMA’s centralized review process for all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. Vimseltinib was granted Orphan Drug designation for the treatment of TGCT by the EMA in December 2019.