RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 8 > FDA Roundup: Enspryng

FDA Roundup: Enspryng

Posted 19 August 2020 | By Renee Matthews 

FDA Roundup: Enspryng

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Enspryng approved for neuromyelitis optica spectrum disorder
Genentech’s Enspryng (satralizumab-mwge injection) has received approval for treating the rare autoimmune disease, neuromyelitis optica spectrum disorder (NMOSD), in adults who are positive for the anti-aquaporin-4 antibody (anti-AQP4 positive).
The approval is the third in little more than a year for the disease, characterized by inflammation and damage to the central nervous system (CNS) and the optic nerves and spinal cord, in particular. In some patients, the disease is associated with antibodies that bind to the AQP4 protein. That binding triggers the immune system to attack the body’s healthy cells and proteins.
Enspryng’s approval was based on effectiveness and safety findings in adult patients treated for NMOSD in two randomized, placebo-controlled clinical studies. In the first study, 64 of 95 patients were anti-AQP4 positive. Patients who were positive and received Enspryng had a 74% risk reduction for relapse compared with those who were positive but received placebo.
In the second study, 52 of 76 patients were anti-AQP4 positive. Among those positive patients, treatment with Enspryng was associated with a 78% reduction in the number of relapses compared with those receiving placebo. Neither trial showed evidence of the drug’s benefit in patients who were anti-AQP4 negative.
The drug was granted fast track and orphan drug designations.

Tags: FDA, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.