Munich (NetDoktor/NASDAQ/BGEN) – the European approval of the Psoriasis drug Amevive ® (Alefacept) was postponed indefinitely. As the American manufacturer BIOGEN tells calls for studies on the application of the drug before a recovery of the authorisation procedure complementary the European Medicines Agency EMEA (European medical evaluation Agency). In the United States Alefacept was admitted already vulgaris on 31 January for the treatment of moderate to severe psoriasis.

Surprising decision

Not only professionals, is reflected by the latest delay in the procedure of approval of the European but also the manufacturer BIOGEN surprises. After almost 15 year old development the introduction was expected Alefacept for the second quarter of 2003. More than 1,000 patients with chronic Plaque Psoriasis had participated in the so far carried out controlled studies on efficacy and tolerability of the substance (psoriasis vulgaris).

Proceedings may take years

The release in the United States end of January was generally considered positive sign for Europe, because the American approval authority U.S. food and Drug Administration (FDA) enjoys the reputation of being particularly strict criteria to be applied in the approval of new drugs. The repairs required by the EMEA now could take some time: A new concept, the implementation and evaluation is estimated in professionals with several years.

The treatment of severe forms of psoriasis is expensive, and the effects of the previously required combined photo and drug therapy keep not long. Exactly these cases are the indications for the immune modulating drug Alefacept. “In our clinical trials, patients were given the substance for twelve weeks and put off the therapy then over several months.” “During this drug-free interval occurred at many of our patients a long-lasting regression of their disease”, so Dr. Kenneth Gordon, dermatologist at Northwestern University and clinical investigator for Amevive ®.

High price

According to recent information, treatment with Amevive ® would be however not cheap: for the required twelve injections in the weekly cost of more than 12,000 euros fell of according to manufacturer’s specifications accordingly. Approximately one out of three of some 80 million psoriasis sufferers may benefit from the substance of Alefacept if the external treatment alone can produce no satisfactory improvement in skin. For the company BIOGEN, the development of the new active substance is an investment in the future, which must pay off. The delay of the authorisation procedure costs also the biotechnology company now much money. (jr)