FDA Nixes Expanded Simponi® Label In US — More Wood to Chop, Before “Active Psoriatic Arthritis” Labeling


While this additional disease indication was green-lighted in the United Kingdom in March 2011, and the EU, it has hit a snag here in the US. Indeed, Merck is benefitting in Europe, on Simponi® (golimumab) sales for the indication, but it possible that if the US FDA requires additional data of Janssen, for Simponi, and that data doesn’t support the treatment of active psoriatic arthritis, NICE and the EMEA could revisit each of the earlier approvals. [Recall that back on April 15, 2011, Merck settled, and relinquished exclusive marketing rights to the drug in Canada, Central and South America, the Middle East, Africa and the Asia-Pacific area starting July 1, 2011, while keeping rights in Europe, Russia and Turkey. Remicade and Simponi generated $2.8 billion for Merck in 2010. Merck also kept the UK and European Union.]

We’ll keep an eye on this, but here is a bit of Friday’s PR Newswire press report:

. . . [T]he U.S. Food and Drug Administration (FDA) issued a Complete Response letter for the Simponi® (golimumab) supplemental Biologics License Application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis. The application, filed in November 2010, included data from a Phase 3 trial evaluating the effect of Simponi in inhibiting the progression of structural damage and maintaining improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis.

Janssen Biotech, Inc. intends to request an end-of-review meeting with the FDA to thoroughly understand the details of the Complete Response letter and discuss what future steps may be necessary to achieve the intended approval. . . .

Just the same, this is disappointing news for Merck’s franchises, no doubt — even though Merck wouldn’t see any of this future revenue from the US — as Janssen holds the rights to all the US Simponi revenue.

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