The FDA has accepted Genentech’s biologics license application (BLA) for satralizumab based on findings from 2 phase 3 trials that showed effectiveness in reducing risk of relapses in patients with neuromyelitis optica spectrum disorder (NMOSD). Satralizumab was previously granted breakthrough therapy designation for the treatment of NMOSD in December 2018.
The double-blind, placebo-controlled studies evaluated the efficacy and safety of satralizumab over 96-weeks. Overall, 76.1% of patients assigned to satralizumab monotherapy in the SAkuraStar study were relapse-free at 48 weeks, compared to 61.9% who received placebo. At 96 weeks, 72.1% of patients who received treatment with satralizumab were relapse-free, compared with 51.2% of patients in the placebo group.
“The FDA and EMA’s acceptances of the satralizumab applications bring us one step closer to providing a new medicine to thousands of people impacted by NMOSD, and we are working with the health authorities to make satralizumab available as soon as possible,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a statement.
The total population of aquaporin-4 antibody (AQP4-IgG) seropositive and seronegative patients assigned to satralizumab monotherapy saw a 55% decrease in risk of relapse compared to placebo (HR 0.45, 95% CI, 0.23-0.89; P =.0184). Notably, the larger subgroup of seropositive patients, who experience a more severe disease course, saw a reduction in risk of relapses of 74% (HR 0.26, 95% CI, 0.11-0.63; P =.0014).
The SAkuraSky trial assessed the risk of relapses with treatment with satralizumab compared to placebo in combination with immunosuppressant therapy. The overall population saw a 62% reduction in the risk of relapse (HR 0.38, 95% CI, 0.16-0.88; P =.0184), while the group of AQP4-IgG seropositive patients experienced a 79% relapse risk reduction (HR 0.21, 95% CI, 0.06-0.75; P =.0086). Results showed 88.9% and 77.6% of patients in the total population were relapse-free at 48 and 96 weeks, respectively, compared to 66% and 58.7% of patients in the placebo group.
Among AQP4-IgG seropositive patients, 91.5% treated with satralizumab were relapse-free at 48 and 96 weeks, compared with 59.9% and 53.3% of patients in the placebo group.
“Satralizumab has shown robust efficacy sustained for 96 weeks and significantly reduced the risk of relapse across a broad patient population, while offering self-administered subcutaneous dosing every 4 weeks,” Garraway said.
Patients who received satralizumab or placebo experienced similar adverse events during the trial, though satralizumab-treated patients saw a lower rate of infections, including serious infections. Patients in the SAkuraStar trial who received satralizumab experienced mild to moderate adverse events, including urinary tract infection and upper respiratory tract infection, while those included in the SAkuraSky study experienced upper respiratory tract infection, nasopharyngitis, and headache.
This content originally appeared on NeurologyLive. Stay tuned for an exciting announcement.
FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder [news release]. San Francisco, CA: Genentech. October 29, 2019. biospace.com/article/releases/fda-accepts-genentech-s-biologics-license-application-for-satralizumab-for-neuromyelitis-optica-spectrum-disorder/. Accessed October 30, 2019.