Article Date: 17 Nov 2010 - 7:00 PST
An FDA Arthritis Advisory Committee voted 13 to 2 in favor of approving Benlysta (belimumab), a lupusmedication. The FDA (Food and Drug Administration) Advisory Committee consists of 15 outside experts, their recommendations are not binding, however, the FDA nearly always goes along with what they recommend. Benlysta was developed by GSK (GlaxoSmithkline) and Human Genome Sciences.
A Human Genome Sciences communiqué states that the Committee has recommended the approval of Benlysta for:
"..autoantibody-positive patients with active systemic lupus erythematosus (SLE)."
If the FDA eventually goes ahead with Benlysta's approval for patients with Systemic Lupus Erythematosus, which is now much more likely, it will be the first new treatment for the condition in over half a century. The Committee also voted that according to reviewed data, the drug appears to be safe and effective. GSK says the FDA should make a decision before the end of this year.
As lupus patients tend to have a wide range of differing symptoms, organizing large-scale clinical trials has been a challenge - this is probably the main reason pharmaceutical companies have found it hard to develop new medications. Although there have been several attempts, apart from this one, all the others have failed.
According to comments today in the financial press, such as The Wall Street Journal, Benlysta sales could top the $5 billion mark by 2020. There are rumors that GSK may now be eyeing Human Genome Sciences Inc. for a takeover.
Lupus is an autoimmune disease - the individual's immune system is overactive and attacks healthy, normal tissue as if it were a foreign pathogen (organism that harms). This results in inflammation (swelling), damage to skin, joints, heart, lungs and kidneys. Experts have identified several types of lupus. The most common is SLE (systemic lupus arythematosus); other types include neonatal, drug induced, and discoid lupus.
About 1.5 million Americans are affected by lupus annually.
Benlysta has been found to help lupus patients with joint pain and severe arthritis-like swelling, skin rash, and kidney inflammation. Benlysta is a fully human monoclonal antibody, it identifies and inhibits (blocks) the activity of B-Lymphocyte stimulator (BLyS), a protein that helps antibody-producing beta cells mature.
The Advisory Committee said that if approved, the labeling should explain that the medication has not been tested on patients with certain problems, such as severe kidney disease.
Human Genome Sciences (HGS) wrote:
"HGS and GSK are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006. Under the agreement, HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement."
Although the medication was only moderately more effective than a placebo in easing lupus symptoms, those on Benlysta were on lower steroid doses. Corticosteroids significantly increase the risk of infection.