Chugai’s Satralizumab Receives FDA Breakthrough Therapy Designation for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Japan-based Chugai Pharmaceutical announced that the FDA has granted breakthrough therapy designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanized 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 3 study (SAkuraSky study, NCT02028884) evaluating satralizumab added to baseline therapy. This is the seventh breakthrough therapy designation received for four drugs created by 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 3 study” Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito, said in a company news release. “Satralizumab is designed to inhibit signaling of the inflammatory cytokine IL-6, which is known to play a role in the pathogenesis of NMO/NMOSD. We continue our efforts to hopefully bring satralizumab as a new treatment option as soon as possible to people living with this devastating disease with no approved drugs.”

Neuromyelitis optica spectrum disorder (NMOSD) is a rare, lifelong, and debilitating autoimmune disease of the central nervous system (CNS) characterized by inflammatory lesions in the optic nerves and spinal cord. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, and loss of quality of life. In some cases, attacks of NMOSD result in death.