The European Commission approved Roche’s injectible drug Enspryng, which can be administered at home to treat neuromyelitis optica spectrum disorder.
Genentech presented new data on Enspryng (satralizumab-mwge), which was approved by the U.S. Food and Drug Administration in mid-August 2020 as a subcutaneous treatment for adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum.
The U.S. Food and Drug Administration approved Roche’s Enspryng for the central nervous system disorder neuromyelitis optica, putting the Swiss drugmaker head-to-head with Alexion’s Soliris in a costly treatment area.
The U.S. Food and Drug Administration approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder who are anti-AQP4 antibody positive.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Genentech released full data from the company’s pivotal Phase III SAkuraStar trial of satralizumab as a monotherapy for NMOSD.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.