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Human Genome Sciences’ lupus drug wins European approval

July 14, 2011

Rockville-based Human Genome Sciences Inc.  has won approval to market its lupus treatment in Europe.

Human Genome Sciences Inc. Latest from The Business Journals Human Genome Sciences cuts quarterly lossHuman Genome Sciences cuts quarterly lossFood and Drug Administration chief Margaret Hamburg touts changes to speed up drug reviews Follow this company has won approval to market its lupus treatment in Europe.

Human Genome (NASDAQ: HGSI) said Thursday that the European Commission had granted marketing authorization for Benlysta, as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.

The U.S. Food and Drug Administration approved Benlysta on March 9, making it the first new treatment for lupus in the U.S. in more than fifty years. Benlysta was brought to market in partnership with London-based GlaxoSmithKline    GlaxoSmithKline Latest from The Business Journals GlaxoSmithKline pursuing own quadrivalent flu vaccineGlaxoSmithKline seeking approval for new flu vaccines With Oral-B, Procter & Gamble stalks South America Follow this company .

Sales of Benlysta in Europe, the second biggest market for the drug after the U.S., are expected to begin slowly with the introduction of Benlysta into just one major EU nation this year.

“We are particularly honored to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development,” said Human Genome Sciences CEO H. Thomas Watkins. “We and GlaxoSmithKline are committed to making Benlysta available in countries worldwide.”

Read the full article here

Source bizjournals.com


Human Genome Sciences’ lupus drug wins European approval

July 14, 2011

Rockville-based Human Genome Sciences Inc.  has won approval to market its lupus treatment in Europe.

Human Genome Sciences Inc. Latest from The Business Journals Human Genome Sciences cuts quarterly lossHuman Genome Sciences cuts quarterly lossFood and Drug Administration chief Margaret Hamburg touts changes to speed up drug reviews Follow this company has won approval to market its lupus treatment in Europe.

Human Genome (NASDAQ: HGSI) said Thursday that the European Commission had granted marketing authorization for Benlysta, as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.

The U.S. Food and Drug Administration approved Benlysta on March 9, making it the first new treatment for lupus in the U.S. in more than fifty years. Benlysta was brought to market in partnership with London-based GlaxoSmithKline    GlaxoSmithKline Latest from The Business Journals GlaxoSmithKline pursuing own quadrivalent flu vaccineGlaxoSmithKline seeking approval for new flu vaccines With Oral-B, Procter & Gamble stalks South America Follow this company .

Sales of Benlysta in Europe, the second biggest market for the drug after the U.S., are expected to begin slowly with the introduction of Benlysta into just one major EU nation this year.

“We are particularly honored to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development,” said Human Genome Sciences CEO H. Thomas Watkins. “We and GlaxoSmithKline are committed to making Benlysta available in countries worldwide.”

Read the full article here

Source bizjournals.com



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