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Positive opinion on Raptiva in Europe

Published on 24/06/04 at 04:05pm

Raptiva, a new psoriasis treatment to be marketed by Serono in Europe has gained a positive opinion from the EMEA.

The newly renamed Committee of Medicinal Products for Human Use (CHMP) recommendation means the drug should gain final clearance in the third quarter of this year, with launches shortly afterwards, adding a significant new treatment option for sufferers of the condition.

Raptiva (efalizumab) is a humanised antibody which works by blocking the T-cells which cause skin cells to grow abnormally and in patients with plaque psoriasis causes lesions to form.

The drug will be licensed to treat adults with moderate to severe chronic plaque psoriasis who have failed to respond to or who have contraindications or intolerance to other systemic treatments including cyclosporin, methotrexate and PUVA, an ultraviolet light and drug combination treatment.

Unpleasant side-effects are common in all of these drugs and Serono hope that the once weekly injections of the drug, administered at home by the patient will be more tolerable and convenient for patients and healthcare professionals.

The Swiss biotech company has licensed the drug outside the US and Japan from US biotech Genentech, which has retained US marketing rights with partner XOMA.

Serono forecasts peak sales of $250-400 million for its territories, but some analysts are less optimistic - Raptiva and Biogen Idec's similar product Amevive (alefacept) have seen slow uptake in the US following their launches last year.

The drugs face stiff competition from the TNF-blocker drugs, Wyeth/Amgen's Enbrel, Schering-Plough's Remicade and Abbott's Humira, which all have potential to treat plaque psoriasis. Enbrel recently became the first in the class to gain a US licence for the disease, supplementing its licence to treat psoriatic arthritis.


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