Human Genome Sciences: FDA Postpones Ruling on Benlysta

LRI President Margaret G. Dowd: “Although the FDA has postponed until March its decision on whether to approve Benlysta, the LRI remains encouraged by last month’s Arthritis Advisory Committee vote to recommend the drug’s approval for active lupus.”

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