Centocor/S-P file golimumab for approval in Europe

Centocor and Schering-Plough are seeking permission to market their once-monthly injection golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in Europe.

Golimumab is currently being assessed in “the most comprehensive Phase III development program to date for an anti-tumour necrosis factor-alpha biologic therapy”, the firms claim, and the drug has certainly shown promise in the trials conducted so far.

In one Phase III study, more than half of patients receiving monthly subcutaneous injections of golimumab experienced significant and sustained improvements in the signs and symptoms of active ankylosing spondylitis, while, in another, 51% of patients treated with the 50mg dose and 48% given 100mg achieved a 50% cut in disease activity after six months’ therapy.

In addition, patients with active psoriatic arthritis receiving monthly subcutaneous injections of golimumab experienced significant and sustained improvements in the joint and skin manifestations of the disease, with 51% of those receiving the 50mg dose and 45% given 100mg experiencing at least a 20% improvement, compared with 9% in the placebo arm.

Filing ‘unprecedented’
According to the firms, the European submission for golimumab is unique as it marks the first time that an anti-tumour necrosis factor-alpha therapy has been tested and put forward for the treatment of “three unique disease states” at the same time.

If the application is successful and regulators issue a green light, Schering-Plough will assume exclusive marketing rights to the drug in the region, while Centocor holds rights to the US.