Later this week, on Thursday March 10, 2011, regulators at the the Federal Food & Drug Administration (FDA) are scheduled to rule on the pending recommended U.S. marketing approval of Benlysta. If approved, this will be the first new drug approved specifically for the treatment of lupus in over 50 years. Initially expected to be approved in November, 2010, the final decision was postponed to this month.
Benlysta’s approval is likely to help many of the estimated 1.5 million patients in the U.S. with lupus and over 5 million world wide. The only three drugs currently approved by the FDA for the treatment of systemic lupus are aspirin, prednisone and plaquenil. This small arsenal of approved drugs is augmented by physicians drawing from drugs approved for other autoimmune diseases, such as rheumatoid arthritis and from cancer and transplant anti-rejection medications.
Successful phase III clinical trials of the biologic drug, Benlysta, were completed involving 2,000 lupus patients and used a new measurement tool for determining the successfulness of the drug in treating lupus. The FDA approved use of the new measuring approach, that combines aspects of several standard lupus activity measures currently in use by physicians and researchers.
To read more about the pending FDA approval of Benlysta for treatment of lupus, check out these recent articles:
- March 8, 2011 – FierceBiotech – Confidence grows in mega-blockbuster approval for HGS’s Benlysta – by John Carroll
- March 8, 2011 – FierceBiotech – GlaxoSmithKline – The world’s biggest R&D spenders – by John Caroll – “…it’s on the verge of hearing the final word from the FDA on Benlysta, the groundbreaking new lupus drug…”
- March 7, 2011 – Medical News Today – Benlysta For Lupus Likely To Be Approved This Thursday, A Potential Blockbuster – by Christian Nordqvist
- March 7, 2011 – Gazette.Net, Maryland Community News Online – Day of reckoning for HGS? Rockville biotech expects FDA ruling on lupus drug Thursday – by Lindsey Robbins – Approval of first new FDA approved drug for lupus, Benlysta, for marketing in U.S. by Human Genome Sciences and GlaxoSmithKline is highly anticipated on March 10th.
- January 21, 2011 – Washington Business Journal – Human Genome Sciences brings on former Wyeth executive – by Jeff Clabaugh – Human Genome Sciences is the company poised to market the new lupus drug Benlysta with its partner GlaxoSmithKline, if it is approved by the FDA in March.
Benlysta’s potential approval has a personal side for me. As a lupus patient who participated in the Phase III clinical trials of Rituxan, I understand the life-changing impacts of a powerful and effective drug treatment. My improvement after receiving two Rituxan infusions was dramatic, shutting down lupus’ attack on my central nervous system and liver, and greatly quieting the overall activity of my disease for almost five years!
Unfortunately, some lupus patients were not helped by Rituxan, and there were a couple of statistically significant deaths of lupus patients who had received it during the clinical trials. Research excitement about use of this drug to treat lupus cooled significantly after 2006 when the news of these brain infection related deaths was released. Although not approved by the FDA for lupus, due to some inconsistent results and these safety concerns, it is now FDA approved and widely used for successful treatment of rheumatoid arthritis.
Although Benlysta is thought to provide less dramatic improvement than what I experienced after receiving Rituxan, it is exciting to finally see the advent of a new drug for lupus. This may be the first new drug approved for lupus in my lifetime, and it might even be available soon to help me.