US drugmaker Schering-Plough and its partner Centocor, a unit of Johnson and Johnson, have obtained approval from the European Medicines Agency to sell their anti-inflammatory drug Remicade (infliximab) for the treatment of plaque psoriasis.
Approval of the drug for this use was based on strong data from the SPIRIT (Study of Psoriasis with Infliximab Remicade Induction Therapy) and EXPRESS (European Infliximab for Psoriasis Remicade Efficacy and Safety Study) trials, which not only illustrated the agent’s efficacy but also re-affirmed its safety profile.
The broad utility of Remicade is evidenced by the growing line of indications it has been cleared for in both Europe and the USA since its first launch in 1998 as a therapy for Crohn’s disease. Since then, Remicade has been approved for conditions such as rheumatoid arthritis, ankylosing spodylitis and psoriatic arthritis and, last month, it gained a US thumbs up for the treatment of ulcerative colitis, marking the first biologic to be cleared for the condition, a chronic inflammatory bowel disease [[19/09/05d]].
Psoriasis affects around 1%-to 5 % of the population in Europe, and if Remicade gains a substantial slice of this market, as well as in other areas for which it is newly-approved, its performance should see a substantial boost. Not that it particularly needs it - in 2004, the drug pulled in impressive revenues of $2.15 billion.