Thalidomide Closer To US Market For Leprosy

Thalidomide has been recommended for approval by a US Food and DrugAdministration advisory committee, and now looks set to reach the market again for the treatment of certain complications associated with erythema nodosum leprosum, a severe and debilitating condition associated with leprosy.

Thalidomide was originally promoted as a sedative, but was withdrawn from the market in Europe in 1961 after it was found to cause limb deformities in around 12,000 babies born to women given the drug during pregnancy. Those exposed to the drug in utero most commonly exhibited stunted or absent limbs, but were generally healthy in all other respects. Thalidomide was never approved for marketing in the USA and, worryingly, in a survey carried out by the FDA, more than 50% of a random sampling of US citizens had not heard of the drug.

Benefits Outweigh Risks The FDA's Dermatologic and Ophthalmic Advisory Committee voted eight to one that the benefits of Celgene's Synovir formulation of thalidomide outweigh its risks in the treatment of systemic ENL syndrome, with one abstention. The FDA's Murray Lumpkin asked the panel for a perspective from the medical community on the benefits and risks of the drug to assist the agency in its review process, not just for Synovir, but for thalidomide in general.