Schering-Plough has announced that the Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion recommending approval of expanded labeling for REMICADE(R) (infliximab), in combination with methotrexate, for treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to disease modifying anti- rheumatic drugs (DMARDs).
Psoriatic arthritis is a chronic autoimmune inflammatory condition involving the joints and the skin.
The positive opinion for REMICADE as a treatment for PsA is primarily based on data from IMPACT (Infliximab Multinational Psoriatic Arthritis Controlled Trial)(1), a randomized, double-blind, placebo-controlled study involving 104 patients with active PsA who had failed at least one DMARD and were enrolled at nine centers in the United States, Canada and Europe. Results demonstrated the safety and efficacy of REMICADE in treating this debilitating disorder.
In IMPACT, patients given REMICADE (5mg/kg) experienced rapid and sustained improvement in their joints, as measured by the ACR 20, 50 and 70 response criteria, measurement tools used to assess disease activity and improvement. Specifically, 34 of the 52 patients (65.4 percent) met the ACR 20 response criteria -- the primary efficacy parameter -- at week 16, compared to five of the 52 patients (9.6 percent) in the placebo group. Responses were sustained through the end of the study (week 50). Results were confirmed in the ACR 50 and ACR 70 scores among those treated with REMICADE: 24 patients (46.2 percent) met the ACR 50 response at week 16 with 26 patients (53.1 percent) meeting it at week 50; 15 patients (28.8 percent) met the ACR 70 response at week 16, with 19 patients (38.8 percent) meeting it at week 50.
The CHMP recommendation serves as the basis for a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all EU-Member states, including the current 15 member states and the 10 new accession countries as well as in Iceland and Norway.
Schering-Plough markets REMICADE in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product. Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States. Centocor plans to submit a supplemental Biologics Application to the U.S. Food and Drug Administration later this year to request approval for this new use.