Satralizumab wins FDA approval for NMOSD

The FDA has approved satralizumab (Enspryng) for neuromyelitis optica spectrum disorder (NMOSD), making Genentech’s drug the first and only injectable treatment for the rare disease.

Intended for individuals with anti-aquaporin-4 (AQP4) antibody positive NMOSD, the monoclonal antibody inhibits interleukin-6 receptor activity using a novel recycling antibody technology that provides a longer duration of drug circulation than conventional methods. After receiving the initial loading dose, patients can self-administer the drug every 4 weeks.

“Having an approved therapy that can be administered subcutaneously in the home and has demonstrated an impact on the frequency of relapses is an important advancement for patients,” explained University of Colorado’s Jeffrey Bennett, MD, PhD, who was an investigator in one of satralizumab’s pivotal clinical trials.

The FDA’s decision was based on a pair of randomized clinical phase 3 trials—SAkuraStar and SAkuraSky—demonstrating the drug’s robust and sustained efficacy. Nearly 77% of patients treated with satralizumab alone and 91% of those treated concurrently with baseline immunosuppressant therapy were relapse free for 96 weeks. The most common adverse reactions were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue and nausea. Although approved for adults, it is not known if the drug is safe and effective in children.

Satralizumab, which is already approved in Japan and Switzerland, is expected to hit U.S. markets in 2 weeks. The FDA has now approved 2 NMOSD drugs over a short time span; the first was Viela Bio’s inebilizumab which was cleared earlier this summer.