FDA Approves Human Genome (HGSI) Lupus Treatment Benlysta (GSK)
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The U.S. Food and Drug Administration approved on Wednesday the lupus treatment Benlysta developed by Human Genome Sciences Inc. (NASDAQ: HGSI), which will be co-marketed in the U.S. with GlaxoSmithKline (NYSE: GSK).
Shares of Human Genome were halted in aftermarket movement on Wednesday prior to the announcement.
“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The treatment is designed to treat patients with active, autoantibody-positive lupus and is the first FDA approved treatment for lupus since 1955.
It is estimated that the number of lupus sufferers in the U.S. ranges from 300,000 to 1.5 million people.
The FDA noted that the disease can impact people of all races, but African American Women have a three times higher incidence than Caucasian women. The studies did show that the patient of African American heritage did not appear to respond to Benlysta.
"To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients," the FDA said.
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Shares of Human Genome were halted in aftermarket movement on Wednesday prior to the announcement.
“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The treatment is designed to treat patients with active, autoantibody-positive lupus and is the first FDA approved treatment for lupus since 1955.
It is estimated that the number of lupus sufferers in the U.S. ranges from 300,000 to 1.5 million people.
The FDA noted that the disease can impact people of all races, but African American Women have a three times higher incidence than Caucasian women. The studies did show that the patient of African American heritage did not appear to respond to Benlysta.
"To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients," the FDA said.
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