Described as a historic approval by the Wall Street Journal, The FDA’s approval of Human Genome Sciences' (Nasdaq:HGSI) Benlysta is the first new drug for treating the autoimmune disease lupus in more than 50 years. It’s also a milestone in science, as it’s the first approved drug derived from genomics, the study of genes and their functions.
Shares of the company are up 10% from its Wednesday closing price of $25.68 during pre-market trading after the company announced that U.S. regulators have approved BENLYSTA® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
“We and GSK are honored to have the opportunity, with the approval of FDA, to bring BENLYSTA forward in the United States as the first new drug for systemic lupus in more than 50 years,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We expect to have this novel therapy available to physicians and patients within about two weeks, and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus.”
The Food and Drug Administration approved Benlysta on Wednesday as a treatment for flare-ups and pain caused by the autoimmune disease lupus. The FDA had not approved a new treatment for lupus since the 1950s, and analysts expect Human Genome Sciences and its partner GlaxoSmithKline PLC to report billions of sales a year. The companies will share the profits from Benlysta.
Human Genome Sciences reported $157.4 million in revenue last year, but it does not have any products on the market. Most of its revenue came from a terminated partnership with Novartis AG, and the rest came from sales of an anthrax treatment to the U.S. government and from manufacturing and development work.
The company said Wednesday that a year of treatment with Benlysta will cost $40,000 for the first year and $35,000 for each year after that.
Analysts expect strong sales because it has been so long since any new lupus therapies reached the market. But they cautioned that evidence of Benlysta's effectiveness is mixed: it works on about a third of all patients, and is not effective for those with the most severe form of lupus. The FDA told the companies to run a new study of Benlysta to show if the drug works on African-Americans, as results from previous trials did not establish it is effective for those patients.
African-Americans are three times more likely to develop lupus than other groups. In November, FDA advisers said Benlysta should be approved, but they added that other treatments are needed.
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