GSK gets two positive recommendation from EU medicines agency

First, Glaxo and Innoviva received a positive opinion from the European Medicines Agency's committee for medicinal products for human use (CHMP) on the pair's Relvar Ellipta, an inhaled corticosteroid, which is one of the last steps before marketing authorisation is updated by the European Commission.

Later on Friday, CHMP gave a positive opinion recommending marketing authorisation for Shingrix for the prevention of herpes zoster and post-herpetic neuralgia, the most common shingles-related complication, in adults aged 50 years or older

Shingrix, which is given intramuscularly in two doses spaced two-to-six months apart, is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.

The final EC decision on Relvar Ellipta is expected by the end of the first quarter of 2018, with the Shingrix anticipated in April 2018.

GSK's global respiratory chief, Jonathan Sweeting, said: “We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients”.

Mike Aguiar, CEO of Innoviva, added: “Asthma is a persistent condition; management guidelines recommend treatment be individualized until control has been achieved. Today’s positive opinion supports once-daily Relvar Ellipta as an important option for doctors and patients in effectively managing asthma.”

On Shingrix, Thomas Breuer, GSK's chief medical officer of the vaccines unit, said: "Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that around one in three people will develop shingles in their lifetime. Shingrix is specifically designed to overcome the age-related weakening of the immune system and is an important step forward in the prevention of shingles."