Posted by Michael Wonder on 20 Dec 2018
Chugai's satralizumab receives FDA breakthrough therapy designation for neuromyelitis optica and neuromyelitis optica spectrum disorders
19 December 2018 - Designation is seventh for Chugai originated drug.
Chugai Pharmaceutical Co announced that the U.S. FDA has granted breakthrough therapy designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanised recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD).
The designation for satralizumab is based on data from the Phase III study (SAkuraSky study, NCT02028884) evaluating satralizumab added to baseline therapy.
