Glaxo makes European application for antiseptic gel

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.