Antares Pharma's Otrexup approved by FDA for arthritis, psoriasis
Antares Pharma said Monday that the FDA approved Otrexup (methotrexate) for adults with severe active rheumatoid arthritis who displayed insufficient therapeutic response or intolerance to first-line therapy, including full-dosenon-steroidalanti-inflammatory agents. The agency also cleared the subcutaneous therapy for children with active polyarticular juvenile idiopathic arthritis, as well as for the symptomatic control of severe recalcitrant, disabling psoriasis in adults who do not respond adequately to other treatments. Company shares jumped as much as 11 percent on the news.
According to LeRoux Jooste, the drugmaker’s senior vice president of sales and marketing, Otrexup should be launched in early 2014. Antares noted that in clinical testing, the once-weekly product was associated with greater bioavailability than oral methotrexate at every dose. The company said the data «confirm and strengthen the findings of previously published bioavailability data, and highlight the saturable limitations of oral [methotrexate] that result in a bioavailability plateau at 15 mg." The drugmaker indicated that the findings would be presented later this month at the American College of Rheumatology meeting.
CEO Paul Wotton said the approval «validates our proprietary VIBEX Medi-Jet technology, which provides a significant advance in improving health outcomes with high-tech, but easy self-administration of [subcutaneous] medications." Antares noted that Otrexup, which Wotton suggested should have patent protection until at least 2030, is the first FDA-approved subcutaneous formulation of methotrexate that can be self-administeredonce-weekly by patients with a disposable auto-injector. Wotton added that the company has additional products in development, «where this auto-injector technology could provide substantial benefits if the product candidates are approved.»