FDA rejects NDA for Genelabs' lupus drug

The US Food and Drug Administration has issued a not-approvable letterto Genelabs Technologies for its systemic lupus erythematosus drug Aslera (prasterone), a synthetic version of the hormone dehydroepiandrosterone. Genelabs, and development and marketing partner Watson Pharmaceuticals, said that the FDA cited various issues in its letter, primarily relating to the interpretation of efficacy and safety data submitted in the New Drug Application for Aslera.

Shares in Genelabs were down 26 cents to $3.47 after the announcement, which came late in the day on June 26, while Watson dropped $1.25 to $61.23. The news comes as a deep disappointment for the two companies, which suggested in April that they hoped to launch the drug in the middle of this year, with a first-year sales forecast of around $25 million, reports Reuters.

The FDA's decision is not wholly surprising, given that an agency advisory panel which reviewed the Aslera application in April failed to agree on whether the trials of the drug had demonstrated its efficacy in SLE (Marketletter April 30).