Thursday, May 14, 2009
NEW DRUG APPROVED FIGHTS THREE FORMS OF ARTHRITIS
By THE ASSOCIATED PRESS
Published: April 24, 2009
WASHINGTON (AP) — The Food and Drug Administration approved a potential blockbuster drug from Johnson & Johnson on Friday that fights three forms of arthritis caused by immune-system disorders.
The injectable medication, called Simponi, is essentially a follow-up to the multibillion-dollar drug Remicade, which is marketed in the United States by Johnson & Johnson and in Europe and other countries by the Schering-Plough Corporation.
Combined sales of the drug were more than $5 billion last year.
Sales of the new drug would be similarly split between the two companies.
F.D.A. regulators have approved the drug for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, a painful, progressive form of spinal arthritis. All three forms of arthritis are chronic disorders in which the immune system attacks joints, causing stiffness, pain and restricted motion.
The drug is injected under the skin once a month. It is made to be used alongside drugs that suppress the immune system.
Johnson & Johnson and Schering have described the drug as the new standard of so-called tumor necrosis factor blockers, a group of drugs that includes Enbrel from Wyeth and Amgen, and Humira from Abbott Laboratories. Unlike Simponi, those drugs are generally injected once every week or two weeks.
The drug class works by engaging and neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.
The moneymaking potential of Simponi and Remicade is among the reasons Merck & Company, of Whitehouse Station, N.J., is acquiring Schering-Plough for $41.1 billion.