US FDA approved auto-injector Otrexup from Antares Pharma for RA

US company Antares Pharma (NASDAQ: ATRS) has announced the approval of Otrexup (methotrexate) injection by the US Food and Drug Administration.

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. It 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.

Paul Wotton, president and chief executive of Antares Pharma, said: “We are very pleased to receive approval from the FDA for Otrexup because we believe it is an important step up in the standard of care for people living with RA, pJIA and psoriasis. This approval represents a strategic milestone for Antares because we believe it validates our proprietary VIBEX Medi-Jet technology which provides a significant advance in improving health outcomes with high tech but easy self-administration of SC medications. Antares has several other products in development, where this auto-injector technology could provide substantial benefits if the product candidates are approved.” He said the VIBEX proprietary technology is protected by numerous granted patents and Otrexup is protected by several patents until at least 2030.