Medac Pharma announced that the FDA has approved Rasuvo (methotrexate) subcutaneous auto-injector for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.

Rasuvo is a folate analog metabolic inhibitor that inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication.

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Clinical trials in patients with rheumatoid arthritis were conducted using other formulations of methotrexate. In patients with rheumatoid arthritis, effects of methotrexate on articular swelling and tenderness were seen as early as 3–6 weeks. Most studies of methotrexate in patients with rheumatoid arthritis were relatively short term (3–6 months).

Rasuvo single-dose auto-injector will be available in 10 dosage strengths: 7.5mg/0.15mL, 10mg/0.20mL, 12.5mg/0.25mL, 15mg/0.30mL, 17.5mg/0.35mL, 20mg/0.40mL, 22.5mg/0.45mL, 25mg/0.50mL, 27.5mg/0.55mL, and 30mg/0.60mL in 1- and 4-count packs.

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