Saturday, November 13, 2010

Centocor Files Simponi® Application With FDA For Additional Arthritis Indication

Well, this will make Johnson & Johnson's pockets just a little deeper, in mid-2011 (in all likelihood) -- it is seeking an additional indication, from FDA: one for joint damage related to psoriatic arthritis, for Simponi® (it already has that indication for Remicade®, in the US). Simponi was previously approved for rheumatoid arthritis here, and in Europe. See this AP item, from Friday morning (today was hectic with non-blogging responsibilities):

. . . .Centocor Ortho Biotech Inc., a Johnson & Johnson subsidiary, said Thursday it submitted an application to the Food and Drug Administration to expand the use of the injectable drug Simponi in treating patients with active psoriatic arthritis.

Centocor said in a statement it is asking the FDA to approve the use of Simponi to slow the progress of joint damage caused by the arthritis, a "potentially devastating manifestation" sometimes tied to the arthritis. The drug already is approved to treat the disease.

It also is approved to treat rheumatoid arthritis, and Centocor submitted an application last month to the FDA to expand that use to include joint damage from that form of arthritis as well. . . .

Of course, New Merck is desperately trying to retain all non-US rights to the drug, and Remicade (its elder sister) -- in an arbitration now undergoing post-hearing breifing and oral arguments. An answer on that potentially $10 billion question (in the next three years' revenues, alone!) is expected in early 2011. We will keep you apprised.

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