|New lupus drug Benlysta available by end of March|
|Written by Kristen Wegrzyn, Daily Vidette Reporter|
|Sunday, 20 March 2011 18:57|
For the first time in 56 years, the Food and Drug Administration approved an injectable drug called Benlysta, co-developed by Human Genome Sciences and GlaxoSmithKline for the use of treating lupus on March 9. The drug should be available by the end of March.
“Lupus is a complex disease that can affect many or one system in the body. Lupus can move, also, from one system to another. No two cases are exactly alike—making finding one treatment for all lupus patients a challenge,” Mary Dollear, vice president of Health Promotion at the Illinois Chapter of the Lupus Foundation of America, said.
Dollear said although the drug may only directly help a portion of those who have lupus, everyone affected by lupus would benefit from Benlysta.
“Benlysta is the first step in a long journey of acquiring multiple effective treatment of lupus…Overall, the FDA approving Benlysta is great news for the entire lupus community,” Dollear added.
Penelope Fletcher, president and CEO of the Washington, D.C., Maryland and Central and Northern Virginia Chapter of the Lupus Foundation of America, said the drug has been in development for 15 years and will be administered at infusion centers.
“I believe the new drug offers hope for everyone living with this terrible disease. It is not only the first drug approved for use with lupus in over 50 years, but it is also the first drug ever designed specifically for lupus patients,” she said.
The most common side effects during the clinical studies included nausea, diarrhea and fever, as well as infusion reactions, according to the FDA.
“I testified at the FDA hearing in the drug, so I saw the trial results presented. One can never ignore these warnings, but it takes very few incidences to warrant a warning of side effects…However, from everything that I heard at the hearing and that I have learned elsewhere, if I or someone I loved had lupus, I would have no hesitation in using the drug.
“My mother suffered with lupus for decades, and I wish that there had been an alternative like Benlysta that might have relieved some of her pain and complications of the disease. It will not work for everyone, but the potential success of the drug make many lupus patients anxious to try it and see if they are one of the fortunate ones for whom it succeeds,” Fletcher said.
It is not determined whether the drug is effective in African American patients, according to the Lupus Foundation of America.
Lenny Andriuzzi, president and CEO of the New Jersey Chapter of the Lupus Foundation of America, said since the population size of African Americans in the study was not large enough to test the effectiveness of the drug, Human Genome Sciences and GSK have committed to doing a follow up study.
“Because the drug is not for everyone with lupus, it is strongly recommended that the lupus patient consult with [his or her] doctor or doctors. Since this is the first drug approved for lupus in over 50 years we are excited, but measured in our response,” Andriuzzi said.