FDA Breakthrough designation for satralizumab

The US Food and Drug Administration has granted Breakthrough Therapy Designation for the anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD).

The drug was developed by Japan’s Chugai Pharmaceutical (TYO; 4519). Which is majority owned by Roche (ROG: SIX), and marks the seventh Breakthrough designation for Chugai.

“Satralizumab is a recycling antibody created utilizing Chugai’s proprietary antibody engineering technologies. We are delighted by the FDA’s designation for this innovative antibody based on the results of a Chugai-initiated global Phase III study” said Chugai’s executive vice president, co-head of Project & Lifecycle Management Unit, Dr Yasushi Ito.