FDA Approves Antares Pharma's Otrexup Injection - Quick Facts

(RTTNews) - Antares Pharma Inc. (ATRS) announced Monday that the U.S. Food and Drug Administration or FDA has approved Otrexup or methotrexate injection. Otrexup is indicated for adults with severe active rheumatoid arthritis or 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 or NSAIDs, or children with active polyarticular juvenile idiopathic arthritis or 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.

Otrexup is the first FDA approved subcutaneous or SC methotrexate or MTX for once weekly self-administration with an easy-to-use, single dose, disposable auto injector.

The company said it expects the commercial launch of OTREXUP in early 2014 will make a meaningful difference in the lives of people living with RA, pJIA and psoriasis and believes also introduces the potential for a cost effective treatment option for physicians.