Federal regulators, which were scheduled to issue a decision on a new drug to treat lupus next week, have delayed their decision until March.
The drug, known as Benlysta, would be the first new treatment for the autoimmune disease in more than 50 years. It also would provide a needed boost for its developers, Human Genome Sciences and GlaxoSmithKline.
But that boost will be delayed, in a disappointment for the companies and investors.
The Food and Drug Administration has pushed back its review of the drug until March 10, the companies announced this afternoon. The FDA was scheduled to rule on Dec. 9, but requested more information on the drug.
Last month, an FDA panel of outside experts recommended the drug win approval, despite some reservations that it didn't help all demographic groups equally.
Benlysta is safe and effective, and works well enough to outweigh risks of suicide, infection and cancer, and should be approved, the panel recommended.
Human Genome Sciences and GlaxoSmithKline have worked together on the drug since 2006, and will split future profits. Shares of both companies fell late today. Analysts expect annual sales of the drug could reach $2 billion.
GSK has been handling some legal, regulatory and other support work for Benlysta out of Research Triangle Park, where the British drug maker employs nearly 5,000 people. The clinical work has been handled in Pennsylvania.
Company executives have said the drug could be available in early 2011, but the FDA's delay will push back its introduction.