Janssen files BLA for IV form of Simponi for moderate-to-severe RA

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech has submitted a Biologics License Application to the US Food and Drug Administration) for approval of an investigational intravenous formulation of the anti-tumor necrosis factor (TNF)-alpha Simponi (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

An estimated 1.5 million Americans are living with RA, a chronic autoimmune disease that causes pain, stiffness and inflammation in the joints, and may lead to irreversible joint damage. Simponi is already approved in 57 countries for adult rheumatologic indications, including the USA. The product is available either through the SmartJect autoinjector or a prefilled syringe as a subcutaneously administered injection and generated sales of $1.52 billion in the second quarter of 2012.

"We are pleased to present the FDA with an application supporting the efficacy and safety of an intravenous formulation of Simponi seeking its approval for the treatment of moderately to severely active rheumatoid arthritis," said Jerome Boscia, vice president, head of Immunology Development, Janssen Research & Development, adding: "Upon approval, an intravenous formulation of Simponi would offer rheumatologists and people affected by this chronic, immune-mediated inflammatory disease an important new t