Human Genome Sciences: FDA Postpones Ruling on Benlysta

LRI President Margaret G. Dowd comments: “Although the U.S. Food and Drug Administration (FDA) has postponed until March its decision on whether to approve Benlysta, the LRI remains encouraged by last month’s FDA Arthritis Advisory Committee’s vote to recommend the drug’s approval for the treatment of active lupus.”

Monday, December 6, 2010

Agency won't issue decision on lupus treatment until March

“We commend the FDA for its commitment to thoroughly reviewing all of the available data prior to making a decision, and Human Genome Sciences and GlaxoSmithKline for their commitment to lupus patients, who have not seen an approved treatment for lupus in over 50 years.

We look forward to the FDA’s further review of the requested information and their decision now scheduled for March 2011.”

- LRI President Margaret G. Dowd

Read the article by the Gazette.Net’s Robert Rand