FDA Approves Human Genome (HGSI), Glaxo Drug Benlysta

The first new drug to treat lupus in over 50 years won U.S. approval on Wednesday. Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK) said that the U.S. Food and Drug Administration [FDA] has approved ‘Benlysta’, an injectable drug designed to relieve flare-ups and pain caused by the disabling disease. Benlysta was discovered by biotech drugmaker Human Genome Sciences to combat lupus, a disease that makes the immune system attack the body’s own tissue and organs.

“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, Human Genome Sciences. “We expect to have this novel therapy available to physicians and patients within about two weeks”

Biotech drugmaker Human Genome Sciences spent 15 years developing the drug. A $125 million investment from Glaxo’s predecessor company, SmithKline Beecham Corp., supported the effort. HGSI will co-market and split the profits with GlaxoSmithKline.

Benlysta, a potential blockbuster for HGSI, could reach annual sales exceeding $3 billion within five years, according to Thomson Reuters consensus forecasts. Some analysts predict sales as high as $5 billion in later years. Human Genome Sciences estimates the initial market for Benlysta is about 325,000 patients.

HGSI was halted pending the release of the FDA news after the market’s close Wednesday. Glaxo shares rose $1.36, or 3.5%, to $39.94 in extended trading, from an earlier close of $38.58 in regular trading on the NYSE.

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