Biotech drugmaker Human Genome Sciences Inc. said Friday a European committee has endorsed its lupus treatment Benlysta, a key step toward possible approval in the European Union.
The Rockville, Md., company said the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval. The European Commission, which approves medicines for the European Union, usually makes a decision on these recommendations in two or three months.
Human Genome Sciences developed Benlysta, which received U.S. regulatory approval in March, and is marketing it with British drugmaker GlaxoSmithKline PLC.
Benlysta became the first new drug to treat lupus in more than 50 years when the Food and Drug Administration approved it March 9, and analysts estimate that sales of the drug could exceed $3 billion within five years.
Benlysta is an injectable drug designed to relieve flare-ups and pain caused by lupus, a potentially fatal ailment in which the body attacks its own tissue and organs. Human Genome Sciences spent 15 years developing the drug.
Human Genome Sciences will discuss the positive opinion during a Friday morning conference call. The company's shares rose 32 cents to $28.30 in premarket trading. Meanwhile, U.S.-traded shares of GlaxoSmithKline fell 41 cents to $43.22.