AEGiS-Reuters: Once-dreaded Thalidomide hits U.S. market

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Once-dreaded Thalidomide hits U.S. market

Reuters NewMedia - Thursday October 1, 1998

WASHINGTON, Oct 1 (Reuters) - Thalidomide, a drug once dreaded for causing severe birth defects but now the source of great hope for treating diseases ranging from cancer to AIDS, hit the market in the United States on Thursday. Celgene Corp., (Nasdaq:CELG - news) which won Food and Drug Administration (FDA) approval for the drug in July, said it was now available nationwide. It is subject to unprecedented controls to to try make sure that pregnant women do not take it.

The drug, made under the brand name Thalomid by New Jersey-based Celgene, is licensed for use to treat a side-effect of leprosy known as erythema nodosum leprosum (ENL), a painful condition that causes bumps under the skin. But it is being tested for a range of other diseases.

"Celgene is currently supporting clinical studies with Thalomid in the areas of cancer, HIV/AIDS, dermatology and gastroenterology." the company said in a statement.

"Specific cancer studies include multiple myeloma, leukemia, glioblastoma, renal cancer, cancer cachexia (the wasting caused by cancer) and colorectal cancer. Ongoing trials in the area of HIV/AIDS include AIDS-related cachexia and aphthous (mouth) ulcers."

Thalidomide was widely prescribed in Europe in the 1950s as a tranquilizer and against morning sickness. But it was found to cause severe birth defects. It has been used for 20 years in the United States to treat leprosy, also known as Hansen's disease, under a special license which only allowed for compassionate and experimental applications. It is also used widely in countries like Brazil.

Because it stops the development of blood vessels, a process known as angiogenesis, Thalidomide has some astonishing possibilities in helping stop the growth of tumors. But this same quality affects limb development in a growing fetus.

The FDA and Celgene have worked out the strictest program ever put into place for a new drug in the hope of avoiding any birth defects. Women using it who are of childbearing age must agree to use two forms of contraception and to undergo regular pregnancy tests.
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