Johnson & Johnson has put in applications on both sides of the Atlantic to expand the use of its psoriasis drug Stelara.
The company said that its daughter firms Janssen Biologics and Janssen Biotech have submitted a supplemental Biologics License Application to the US Food and Drug Administration and a Type II Variation to the European Medicines Agency seeking approval of the drug for the treatment of adult patients with active psoriatic arthritis.
If successful, around two million patients in the US and more than four million in Europe could gain access to Stelara (ustekinumab) for the condition, a chronic immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.
Tumour necrosis factor inhibitors are currently the only approved biologic therapies available to treat psoriatic arthritis “and additional therapeutic options are needed,” said Jerome Boscia, Vice President, Head of Immunology Development, Janssen Research & Development.
He also stressed that the safety and efficacy of Stelara in this setting has evaluated in a large Phase III clinical development program.
Stelara is a human interleukin (IL)-12 and IL-23 antagonist currently approved in 69 countries for the treatment of moderate-to-severe plaque psoriasis, pulling in third-quarter sales of $287 million.
The drug is also currently in late-stage development for the treatment of moderately-to-severely active Crohn’s disease.
