Health Canada approves Johnson & Johnson, Schering-Plough arthritis treatment

KENILWORTH, N.J. Health Canada has issued the first regulatory approval of a drug by Johnson & Johnson and Schering-Plough for treating arthritis, J&J announced Monday.

The company said the regulatory agency approved Simponi (golimumab), a monoclonal antibody administered monthly for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. J&J said Simponi, made by subsidiary Centocor Ortho Biotech, is the first biotech drug to be approved concurrently for three rheumatologic diseases.

“This first approval marks a major milestone in the clinical development program for Simponi,” said Centocor Research and Development SVP clinical R&D Jerome Boscia said. “More importantly, the approval of Simponi expands the therapeutic options for physicians and offers patients an effective new medication that can be self-administered once monthly.”

Pending regulatory approval, Centocor will have exclusive marketing rights to Simponi in the United States. J&J subsidiaries Janssen-Cilag and Xian-Janssen will have marketing rights in Hong Kong and mainland China, respectively, while Mitsubishi Tanabe Pharma Corp. and Janssen Pharmaceutical Kabushiki Kaisha will co-market the drug in Japan, Indonesia and Taiwan. Schering-Plough will have exclusive marketing rights elsewhere outside the United States. Centocor announced in June 2008 that it had submitted an approval application to the Food and Drug Administration to market the drug in the United States.