Rasuvo methotrexate regulatory update

FDA approved an NDA for Rasuvo methotrexate - an autopen containing subcutaneous injectable methotrexate - to manage severe, active rheumatoid arthritis, active polyarticular juvenile idiopathic arthritis (pJIA) and severe, recalcitrant, disabling psoriasis. The drug is indicated in RA and pJIA patients who are intolerant of or had an inadequate response to first-line therapy and in adult patients with psoriasis who are not adequately response to other forms of therapy. The company said it plans to launch the product in the U.S. by year end, but has not yet finalized pricing.

Medac submitted the NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. Medac markets a different strength of Rasuvo as Metoject in at least 23 countries, including Russia, Canada and some countries in Europe. ...