Glaxo makes European application for antiseptic gel

GlaxoSmithKline has submitted a regulatory application to the European Medicines Agency for its antiseptic chlorhexidine gel for the prevention of umbilical cord infections in newborn babies.

Glaxo said the EMA has granted the application accelerated assessment, a process open to medicinal products of major public health interest and under which the EMA intends to provide a scientific opinion on the submission in a reduced timeframe of 150 days.

The antiseptic gel is intended exclusively for use in developing countries and, if approved for use, GSK will offer it at a not-for-profit price and will share its manufacturing knowledge with others to enable it to be made locally.

Dr Pauline Williams, head of Global Health R&D at Glaxo said: “We are delighted to have reached this significant milestone, which brings us a step closer to help protect newborns from umbilical cord infection.

The combination of GSK’s scientific, regulatory and manufacturing capabilities and Save the Children’s on-the-ground knowledge presented us with a unique opportunity to develop a medicine, by reformulating an existing product, to meet a priority need for newborns in developing countries.”

At 0820 BST, GSK shares were down 0.9% at 1,298p.