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J&J files intravenous Simponi formulation in US

FDA approval would complement J&J’s current subcutaneously-administered product

Johnson & Johnson is seeking approval of a new intravenous formulation of its rheumatoid arthritis (RA) drug Simponi in the US to complement its current subcutaneously-administered product.

First launched in 2009, Simponi (golimumab) is a follow-up to J&J's big-selling RA drug Remicade (infliximab) and is a growth product for the company, with sales of the subcutaneous version up almost 50 per cent in the first half of the year to reach $241m.

Underlying growth is hard to gauge, however, as J&J recently amended a marketing agreement for Simponi with Merck & Co and started selling Remicade and Simponi directly in certain international territories, affecting year-on-year growth comparisons.

The intravenous formulation "would offer rheumatologists and people affected by this chronic, immune-mediated inflammatory disease an important new treatment option", commented Jerome Boscia, head of immunology development at J&J's Janssen subsidiary.

The new formulation can be dosed once every 12 weeks, as opposed to once a month with the current subcutaneous injection which can be delivered either by a healthcare practitioner or the patient.

The filing is based on the results of the GO-FURTHER trial, which showed that 60 per cent of moderate-to-severe RA patients treated with intravenous Simponi every 12 weeks achieved a 20 per cent improvement in symptoms such as pain, stiffness and swelling in joints. 

The phase III study achieved significant benefits in patients despite the fact that the population enrolled tended to have more severe disease than in studies of the subcutaneous formulation.

An application requesting approval of an intravenous formulation of Simponi for moderate to severe active RA is currently under review in the EU, noted J&J.

19th September 2012

From: Research, Sales, Regulatory

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