Human Genome Sciences expecting FDA to reject hepatitis C drug Zalbin
Tuesday, June 15, 2010
Rockville-based Human Genome Sciences said Monday that it doubts that federal regulators will approve its treatment for chronic hepatitis C after the drug received an unfavorable preliminary review from the Food and Drug Administration.
The announcement marks a four-day stretch of mixed news for the company, which at the end of last week filed an FDA application for a drug designed to treat systemic lupus.
The hepatitis treatment, called Zalbin, is one of three HGS drugs in late-stage development. The company has submitted biologic license agreements, or BLAs, to the FDA for all three products, although none has been approved.
"The FDA has expressed concerns regarding the risk benefit assessment of Zalbin dosed at 900-mcg every two weeks," HGS said in a statement. "Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely."
A spokesman for the company did not return calls. A spokeswoman with the FDA said that the agency cannot comment on pending applications.
HGS has been developing Zalbin with Switzerland-based Novartis since 2006, although in Europe the treatment is known as Joulferon. Novartis withdrew its application for the drug from the European Medicines Agency in April.
According to its statement, HGS has been testing Zalbin on a four-week dosage regimen and will consider developing it at that interval.
On Thursday, HGS announced it had officially submitted its application to the FDA for Benlysta, which if approved will be the first drug designed to treat systemic lupus in more than 50 years. The news caused the company's shares to jump more than 8 percent Friday.
Wall Street analysts and Washington area biotech experts have predicted that the treatment could fill an unmet medical need for as many as 1 million people and generate billions of dollars in revenue for HGS and GlaxoSmithKline, its London-based partner on the product.
Shares of HGS fell 30 cents, or 1.1 percent, to close Monday at $26.21.