Posted by Michael Wonder on 21 Feb 2019
Modis Therapeutics announces that MT1621 receives breakthrough therapy designation from FDA for the treatment of TK2 deficiency
19 February 2019 - Designation based on compelling data from initial clinical studies and high unmet need in thymidine kinase 2 deficiency.
Modis Therapeutics announced today that the FDA has granted breakthrough therapy designation to MT1621, Modis’ investigational treatment for patients with thymidine kinase 2 deficiency (TK2d).
Modis’ application was supported by data from initial clinical studies in TK2d patients, some of which was presented by Dr. Michio Hirano at the International World Muscle Society Congress in October 2018. MT1621 has also been granted PRIME designation by the EMA and orphan drug designation by both the FDA and EMA.
