Immunex' Enbrel filed for psoriatic arthritis

Immunex has filed for approval to market its anti-tumor necrosis factordrug Enbrel (etanercept) for reducing the signs and symptoms of psoriatic arthritis, either as a monotherapy or in combination with methotrexate, in the USA and Canada. This is claimed to be the first product to be reviewed by the US Food and Drug Administration for this indication, which is estimated to occur in around 10% of patients with psoriasis.

Owing to the lack of approved drugs for this indication, Immunex will seek an expedited review of the supplemental Biologics License Application in the USA which, if accepted, would mean that the drug could secure approval for this use in early 2002.

Enbrel sales totaled $652 million last year, accounting for about 75% of Immunex' turnover, with some analysts reported by Reuters estimating that approval for psoriatic arthritis could add another $400-$500 million over the next few years. However, others note that approval of the new indication may not add significant momentum to Enbrel's robust underlying sales growth, as rheumatologists have already been prescribing the medication off-label for psoriatic arthritis patients for some time.