ROCKVILLE, Md. (AP) — Human Genome Sciences Inc. said today its potential hepatitis C drug Zalbin will likely not gain FDA approval at its current dosage.
The company said the FDA has safety concerns about the proposed 900-microgram, twice-monthly dosage. The FDA feedback was provided via a “discipline review letter,” which is a standard method of communicating a preliminary analysis on possible deficiencies of an application, according to Human Genome.
In April, Human Genome’s partner Novartis AG withdrew a European application for the drug candidate, which is called Joulferon in Europe, because it expected regulators would request more information. The key concern was that additional new data would be requested by regulators.
The companies are also studying the drug in a monthly dose.
