Elan and its US partner Biogen Idec hope to launch multiple sclerosis drug Tysabri in Europe this summer, following a positive recommendation from EU experts, a top Biogen executive said yesterday.
Hans Peter Hasler, head of international business at the US biotech company, said the new drug would be rolled out over a period of about a year in different European countries, with Germany expected to be the most important market initially.
The EU panel decision move represents an important endorsement for Tysabri, which has had a troubled history but is key to both companies' future financial health. Last year Tysabri was pulled abruptly from the US market, where it was first launched, following a link with a rare but life-threatening side effect. Since then a US advisory panel has recommended the drug be allowed back subject to certain risk controls - and that positive view has now been echoed by the European Committee for Medicinal Products for Human Use (CHMP) following a review of clinical trials data and the recent safety review.
Opinions from the CHMP are normally confirmed by the European Commission within a couple of months.
Industry analysts at Lehman Brothers said the suggested labelling for the product meant doctors in Europe could have considerable flexibility over when to use Tysabri. They believe Tysabri could take a 10 per cent market share within two years.
The CHMP recommendation is for Tysabri to be given either to patients with highly active relapsing-remitting MS who have failed to respond to a beta-interferon, or patients who have a rapidly evolving severe relapsing-remitting disease.
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