Roche RHHBY announced that the FDA has approved its pipeline drug, satralizumab-mwge, as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). The candidate has been approved under the brand name, Enspryng.
NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system.
Enspryng is a humanized monoclonal antibody and the only approved therapy designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD.
The FDA approval was supported by results from two randomized, controlled phase III studies — the SAkuraStar and SAkuraSky — in which Enspryng demonstrated robust and sustained efficacy and a favorable safety profile in adults with AQP4 antibody positive NMOSD.
Enspryng is also approved in Canada, Japan and Switzerland. Application is under review in the EU too.
Enspryng enjoys orphan drug status in the United States, Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.
The approval of the drug will strengthen Roche’s neuroscience franchise. We note that the company is currently investigating more than a dozen candidates for neurological disorders, including multiple sclerosis, NMOSD, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder.
We note that Alexion’s ALXN Soliris is also approved for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Last week, the FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children aged 2 months and older. SMA is a severe, progressive neuromuscular disease that can be fatal.
Roche’s stock has gained 4.7% in the year so far compared with the industry’s growth of 0.5%.
The company is a leader in the oncology space and looking to diversify its presence in other areas.
Meanwhile, Roche’s performance in the second quarter was negatively impacted by the COVID-19 outbreak as patients deferred routine visits to the physicians. While the performance in the first quarter was reasonably good, weak performance in the second quarter affected the first-half results.
Strong growth in Ocrevus, Perjeta, Tecentriq and Hemlibra countered biosimilar competition for Herceptin and MabThera from the likes of Amgen AMGN.
Roche is conducting several phase III studies in severe COVID-19 pneumonia. Remdacta, a global phase III study, was initiated to evaluate the safety and efficacy of Actemra/RoActemra in combination with Gilead Sciences’ GILD antiviral, remdesivir.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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