Satralizumab shows positive phase 3 results for neuromyelitis optica spectrum disorder

Satralizumab monotherapy achieved a 55% reduction in the risk for relapses compared with placebo in patients with neuromyelitis optica spectrum disorder, according to a press release from Genentech.

The phase 3 multicenter, randomized, double-masked, placebo-controlled SAkuraStar study evaluated 95 patients with neuromyelitis optica spectrum disorder (NMOSD) between the ages of 20 and 70 years who were randomly assigned 2:1 to receive subcutaneous satralizumab 120 mg or placebo.

Of those treated with satralizumab, 76.1% were relapse-free at 48 weeks, with 72.1% being relapse-free at 96 weeks, compared with 61.9% and 51.2% being relapse-free, respectively, with placebo.

Satralizumab is a humanized monoclonal antibody that targets the interleukin-6 receptor, which is thought to be a key driver of NMOSD.

“While first described 125 years ago, the underlying biology of NMOSD has only recently been understood. The positive results from the pivotal SAkuraStar and SAkuraSky studies support the hypothesis that IL-6 plays a key role in this devastating disease that can take away people’s independence,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release. “We are encouraged by these results and look forward to working with regulators over the coming months to bring satralizumab to people living with NMOSD as soon as possible.”

Satralizumab monotherapy achieved a 55% reduction in the risk for relapses compared with placebo in patients with neuromyelitis optica spectrum disorder, according to a press release from Genentech.

The phase 3 multicenter, randomized, double-masked, placebo-controlled SAkuraStar study evaluated 95 patients with neuromyelitis optica spectrum disorder (NMOSD) between the ages of 20 and 70 years who were randomly assigned 2:1 to receive subcutaneous satralizumab 120 mg or placebo.

Of those treated with satralizumab, 76.1% were relapse-free at 48 weeks, with 72.1% being relapse-free at 96 weeks, compared with 61.9% and 51.2% being relapse-free, respectively, with placebo.

Satralizumab is a humanized monoclonal antibody that targets the interleukin-6 receptor, which is thought to be a key driver of NMOSD.

“While first described 125 years ago, the underlying biology of NMOSD has only recently been understood. The positive results from the pivotal SAkuraStar and SAkuraSky studies support the hypothesis that IL-6 plays a key role in this devastating disease that can take away people’s independence,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release. “We are encouraged by these results and look forward to working with regulators over the coming months to bring satralizumab to people living with NMOSD as soon as possible.”