Johnson & Johnson subsidiary Centocor said yesterday it was given a green light in the USA to change the labelling for its anti-tumour necrosis factor (TNF) drug Remicade in psoriatic arthritis.
Remicade (infliximab) was approved to treat psoriatic arthritis in May 2005, in addition to indications in rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis and ulcerative colitis. The new approval is for labelling that says the drug can inhibit structural damage and improve physical function in patients with active psoriatic arthritis.
Up to 30% of psoriasis patients suffer from psoriatic arthritis, which is characterised by pain, stiffness and swelling in and around the joints.
Remicade is J&J’s third-biggest product, bringing in $1.48 billion in revenues in the first six months of 2006, up nearly 20% year-on-year. The growth in the product – despite increasing competition in the anti-TNF sector – is largely a result of a continued roll-out of new indications, said J&J.
The approval is based on one-year data from the IMPACT 2 trial and two-year data from the earlier IMPACT study. IMPACT 2 showed that after 24 weeks’ treatment, patients on Remicade had less structural damage as assessed radiographically compared with patients receiving placebo and were more than twice as likely to achieve a clinically meaningful improvement in physical function (54% versus 22%, respectively).
