EMA Accepts Ono Pharma's MAA for TGCT Treatment
EMA accepts Ono Pharma's MAA for vimseltinib to treat TGCT, boosting oncology portfolio after Deciphera buy.
Breaking News
Jul 20, 2024
Mrudula Kulkarni
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 tumours (TGCT), according to Japanese manufacturer Ono Pharmaceutical (TYO: 4528). Deciphera Pharmaceuticals, which Ono recently purchased in a transaction estimated to be worth $2.4 billion, is developing the medication.
Qinlock (ripretinib), which had $163 million in worldwide sales in 2023, was also included in the purchase. Ono Pharma has stated in the past that it anticipates vimseltinib and Qinlock combined to achieve a peak in worldwide sales of $1 billion.
Under the EMA's centralised review procedure, which covers all 27 EU members as well as Iceland, Liechtenstein, and Norway, the MAA is first reviewed.
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