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Antares Gets Otrexup Approval

FDA clears methotroxate SC injection

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Antares Pharma has received approval from the FDA for Otrexup (methotrexate) injection. 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. These results confirm and strengthen the findings of previously published bioavailability data, and highlight the saturable limitations of oral MTX that result in a bioavailability plateau at 15mg. These data are included in the approved Otrexup label. The company plans to make a commercial launch of Otrexup in early 2014.

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