FDA approves Otrexup (Antares) for RA, Psoriasis and pJIA

Antares Pharma, Inc. announced the approval of Otrexup (methotrexate) injection by the FDA. Otrexup is the first FDA approved subcutaneous (SC) methotrexate (MTX) for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. Otrexup is indicated for adults with severe active Rheumatoid Arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs), or children with active Polyarticular Juvenile Idiopathic Arthritis (pJIA). The FDA also approved adult use of Otrexup for symptomatic control of severe recalcitrant, disabling Psoriasis that is not adequately responsive to other forms of therapy.

Human study data submitted to the FDA demonstrated increased bioavailability of SC MTX compared to oral MTX at every dose.