Genelabs' Aslera non-approvable

GLNB said it received a non-approvable letter from the FDA for its NDA for Aslera prasterone DHEA as first line therapy in women with mild to moderate systemic lupus erythematosus (SLE). GNLB, which was off $1.52 (44%) to $1.95 on Wednesday, said the letter cited issues related to the interpretation of efficacy and safety data in the NDA. GNLB said it is working with the FDA to address the agency's issues with the NDA.

In April, the FDA's Arthritis Advisory Committee said the data for Aslera did not meet the FDA's traditional standards for demonstrating efficacy and safety, but several panel members said they believed the product has some efficacy, presents little risk, and that if it were approved they would prescribe it for patients (see BioCentury, April 23). The committee did not vote on whether to recommend approval of Aslera. ...