Genelabs - GNLB goes poof, 1.80 now. Got the boot from FDA.
Tuesday June 26, 11:48 pm Eastern Time
FDA issues "not approvable" letter on lupus drug
REDWOOD CITY, Calif., June 26 (Reuters) - Genelabs Technologies Inc (NasdaqNM:GNLB - news), a small-molecule drug developer, and Watson Pharmaceuticals Inc (NYSE:WPI - news) on Tuesday said a U.S. advisory panel did not approve the companies' application for Alsera, a drug used to treat the auto-immune disease lupus.
The companies said the U.S. Food and Drug Administration cited various issues related to the rejection, primarily relating to the interpretation of efficacy and safety data submitted in the new drug application (NDA).
Both Genelabs and Watson Pharmaceuticals had been waiting word from the FDA. The Corona, Calif.-based Watson had said in April it expected to launch Alsera, an oral drug, by mid 2001 if the FDA gave approval. The company has estimated $25 million in net revenue from Alsera for the rest of the year.
Genelabs said in a statement it was committed to working with the FDA to address the deficiencies cited and expected to meet with the agency promptly to clarify the issues raised and the steps required to be taken before the NDA may be approved.
The companies said they intended to continue trying to get the drug approved, as both believed in its potential to improve the lives of women suffering from the debilitating effects of lupus.
About 200,000 people, primarily women, in the United States are diagnosed each year with lupus, a chronic disease that causes the body to attack its own tissue. Effects can range from mild to life-threatening.
Current treatments for lupus usually include anti-inflammatory drugs, steroids or immuno-suppressants. Long-term steroid use can have serious side effects. |
