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Home Industry News Janssen receives US approval for Simponi Aria

Janssen receives US approval for Simponi Aria

22nd July 2013

Janssen has announced that its new Simponi Aria treatment for rheumatoid arthritis has been approved by US regulators.

The US Food and Drug Administration (FDA) has endorsed the drug for infusion in the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.

It is the only fully-human anti-tumour necrosis factor-alpha infusible therapy and has been shown to significantly improve signs, symptoms and physical function, while also inhibiting the progression of structural damage.

This means patients will be able to receive treatment with a short infusion time of 30 minutes and a dosing regimen of every eight weeks.

Dr Jerome Boscia, vice-president and head of immunology development at Janssen Research and Development, said: "The approval of Simponi Aria represents our commitment to bringing forward new therapeutic options for patients living with immunological diseases, including potentially disabling diseases like rheumatoid arthritis."

Earlier this month, the company received a recommendation from Europe's Committee for Medical Products for Human Use for approval of its multiple myeloma drug Velcade in a number of new indications.ADNFCR-8000103-ID-801614934-ADNFCR

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