Genentech Inc., one of leading biotechnology corporations which became a subsidiary of Roche in 2009, has reportedly announced that the U.S FDA (Food and Drug Administration) has reportedly approved Satralizumab for treating adult patients with anti-aquaporin-4 antibody-positive NMOSD (Neuromyelitis Optica Spectrum Disorder).

NMOSD is lifelong, debilitating, and rare autoimmune disorder of the central nervous system primarily damages the spinal cord and optic nerve, causing muscle weakness, blindness, and paralysis. The approval granted to Genentech is only the second targeted treatment for NMOSD patients and the first available treatment for at-home administration.

Satralizumab, which is marketed under the brand name Enspryng, is the monoclonal antibody that inhibits and targets interleukin-6 receptor activity. It apparently plays a key role in the inflammation observed in NMOSD.

Speaking on the treatment, Jeffrey Bennett, who is the investigator for the satralizumab clinical trials said that in patients with NMOSD, relapses could cause irreversible, disabling, and devastating neurological effects. Having an approved therapy as a subcutaneous injection at home has proven to have an effect on the frequency of relapses and is a pivotal advancement for patients, he added.

US FDA’s approval of the treatment was based on the findings from phase 3 clinical trials named SAkuraSky and SAkuraStar for Satralizumab. These clinical trials included over 170 patients who were randomly assigned to receive placebo or satralizumab 120 mg.

Sources cite that all these patients received a loading dose of the Satralizumab at baseline, second week, and the fourth week, followed by four-week treatment intervals. The primary endpoint in both clinical trials was period to protocol-defined relapse.

Notably, both clinical trials included some patients who were anti-aquaporin-4 antibody positive and negative to precisely reflect clinical practice. The most common adverse events observed were headache, nasopharyngitis, and upper respiratory tract infection.

As per Genentech, Enspryng will be available in the United States within 2 weeks. The drug is already approved in Canada, Switzerland, and Japan, with the application under review in China and the European Union.

Source Credit - https://www.hcplive.com/view/fda-approves-neuromyelitis-optica-spectrum-disorder