Tysabri approved in EU

rasnet6 · Family Member Joined: Jul 13, 2004 Posts: 33 Location: uk

Just something i stumbled across this morning

The EU's CHMP has recommended approval of Elan and Biogen Idec's Tysabri (natalizumab), as a monotherapy for multiple sclerosis.

The product, which was launched in the US in late 2004 and voluntarily suspended two months later, has been given the go-ahead in the EU for use to delay the progression of disability and reduce the frequency of relapses in patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting multiple sclerosis.

The US suspension followed two cases of progressive multifocal encephalopathy (PML) in patients receiving concomitant therapy with Avonex (Biogen Idec's interferon beta-1a), and while the EU positive opinion only refers to its use as a monotherapy, it is still a boost for the product while it awaits the final US FDA decision on whether to allow it back on the market there. The US agency recently put off making its decision by three months to June, saying it needed more time to review the proposed risk-management plan for the product.

The EU label is narrower than the original US approval, which did not restrict its use to second-line and covered its use both as a monotherapy and in combination with beta-interferon. Tysabri's use together with Avonex was seen as the biggest threat to other MS therapies.

Recently, an FDA advisory panel recommended that natalizumab should be allowed to return to the market on condition of a strict management programme, but the panel was split on whether Tysabri use should be limited to those patients who have failed on, or are intolerant to, other treatments (Scrip No 3138, p 20).

Elan (which made the European application) said that as part of its review, the CHMP examined the risk management plan to assess and minimise the risks of PML (caused by the JC virus) and other serious opportunistic infections, which have been observed with Tysabri use.

The CHMP says that Tysabri's clinical benefits have been shown in two randomised, controlled trials in which it achieved a higher clinical success rate compared with placebo either as a single disease-modifying agent or in combination with Avonex. Its most common side-effects include gastrointestinal disorders, urticaria, arthralgia, headache, dizziness, fatigue, pyrexia and elevated white blood cell count.

Natalizumab acts mainly by preventing transmigration of a certain group of white blood cells (mononuclear cells) in to inflamed parenchymal tissue to reduce inflammatory activity in the brain in multiple sclerosis. SCRIP - World Pharmaceutical News