Antares Pharma, Inc. today announced that the New Drug Application (NDA) for OTREXUP, a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet technology, has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
Genentech, Inc., a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ACTEMRA (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ACTEMRA can be used both alone as a single-agent therapy and in combination with methotrexate (MTX) or other DMARDs. The expanded indication further supports the safety and efficacy profile of ACTEMRA.
Roche's RoACTEMRA improved rheumatoid arthritis signs and symptoms significantly more than adalimumab as single-agent therapy
NEW YORK (AP) — Regeneron Pharmaceuticals Inc. and Sanofi said a clinical trial showed their drug candidate sarilumab reduced symptoms of moderate to severe rheumatoid arthritis.
The companies said late Tuesday that they are discussing the doses of the drug that will be tested in a late-stage clinical trial. In a mid-stage trial, the companies said patients who were treated with sarilumab and methotrexate improved more than patients who were treated with methotrexate and a placebo.