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Home Industry News Janssen files for EU and US approval of siltuximab

Janssen files for EU and US approval of siltuximab

6th September 2013

Janssen has announced that it has filed for US and European regulatory approval of an innovative new therapy for patients with multicentric Castleman disease (MCD).

Applications have been submitted to the US Food and Drug Administration and European Medicines Agency for the use of siltuximab among MCD sufferers who have tested negative for HIV and human herpes virus-8.

MCD is a rare blood disorder in which lymphocytes are over-produced and leads to enlargement of the lymph nodes, weakening the immune system and making patients seriously susceptible to infections.

There are no approved treatments in either the US or EU for this condition, leading regulators in both territories to grant siltuximab orphan drug status.

Dr Peter Lebowitz, global oncology therapeutic area head at Janssen, said: "By focusing on core biologic mechanisms, we now have the potential of helping patients with a condition that is challenging to treat."

This comes after the firm announced the completion of its takeover of Aragon Pharmaceuticals last month, a move that will enhance its capabilities in the field of cancer research.ADNFCR-8000103-ID-801634426-ADNFCR

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