Human Genome (HGSI) Could Miss 30% of Lupus Market with Benlysta on Uncertain Data
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Human Genome Sciences (NASDAQ: HGSI) was approved by the U.S. Food and Drug Administration on Wednesday for the first Lupus treatment in 56 years, but the company could miss out on a key demographic going forward.
The FDA said that Benlysta did not appear to show a response in African-American patients, but there were not enough patients in the clinical studies to "reach a definite conclusion."
As a condition of the treatments approval, Benlysta will have additional studies in African Americans and people with African heritage. The company said on Wednesday that the there are no limitations on the drug, but such patients should use caution.
There are a higher percentage of African Americans affected by Lupus, representing 20-30 percent of the total potential market for the drug. The total lupus population is estimated to be 300,000 to 1.5 million people.
Shares of Human Genome are up 4.56 percent to $26.88 in premarket trade on Thursday after resuming trade up 16 percent.
The FDA said that Benlysta did not appear to show a response in African-American patients, but there were not enough patients in the clinical studies to "reach a definite conclusion."
As a condition of the treatments approval, Benlysta will have additional studies in African Americans and people with African heritage. The company said on Wednesday that the there are no limitations on the drug, but such patients should use caution.
There are a higher percentage of African Americans affected by Lupus, representing 20-30 percent of the total potential market for the drug. The total lupus population is estimated to be 300,000 to 1.5 million people.
Shares of Human Genome are up 4.56 percent to $26.88 in premarket trade on Thursday after resuming trade up 16 percent.
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