Canadian regulators approve golimumab

Tools

Canadian regulators have approved Simponi (golimumab), a biologic developed by Johnson & Johnson and Schering-Plough. The drug--an update to the blockbuster Remicade--is indicated for severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Simponi requires only montly injections, compared to higher frequencies for existing meds.

"Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients. Simponi expands our leading immunology franchise in meeting the needs of the rheumatology community," said Thomas Koestler, Ph.D., executive vice president, Schering-Plough Corporation and president, Schering-Plough Research Institute.

This marks the first approval for Simponi, which is still awaiting a decision from the FDA. J&J will market the drug in the U.S., while Schering-Plough will be responsible for Simponi in other markets.

- here's the release
- see this report for more

Related Articles:
Golimumab - Next gen biotech blockbusters
Anti-TNF blockbuster garners positive Phase III data