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Thalidomide gains EU licence


Thalidomide has been rehabilitated in Europe after drug regulators granted a US company a licence to market it.

The EC has ruled that the drug, linked to birth defects five decades ago, should be officially recognised as a treatment for blood cancer.

Acting on a recommendation from the EMEA, the commission granted the licence to Celgene Corporation. The US-based global drug company, which now owns thalidomide, sells the drug under the brand name Thalomid®.

In 2006, the FDA approved Thalomid as an oral treatment for newly diagnosed multiple myeloma. Under the new licence it will qualify for the same use in Europe, with strict controls similar to those already enforced in the USA.

Until now thalidomide was available in Europe through a scheme that lets doctors prescribe unlicensed drugs with unknown risks to specific named patients.

Thalidomide UK, the charity that supports the generation of people affected by the drug in the 1950s and 1960s, said there had been few precautions to prevent the birth of more deformed children.

The new licence conditions bring into force a “pregnancy prevention programme” aimed at keeping any risk of further birth problems to an absolute minimum.

Copyright © PA Business 2008


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