EMA Grants Accelerated Assessment for GSK’s Antiseptic Gel
European regulators have granted accelerated assessment for GlaxoSmithKline’s antiseptic chlorhexidine gel for the prevention of umbilical cord infections.
The product, intended exclusively for use in developing countries, is the first to be developed through GSK’s two-year-old partnership with Save the Children. If approved, the drugmaker will offer the antiseptic at a not-for-profit price and share its manufacturing knowledge with others so it can be made locally.
Under an accelerated assessment, the European Medicines Agency provides a scientific opinion in 150 days instead of the standard 210 days — putting the drug on target for approval in March 2016.
The product would also need local approval from national regulatory authorities in countries with regions of moderate to high neonatal mortality rates. Availability could occur as soon as early 2017, a GSK spokeswoman said. — Jonathon Shacat