GSK's meningitis-B vaccine gets FDA fast-track boost

A meningitis vaccine developed by GlaxoSmithKline has been given a 'breakthrough therapy' status by US drug regulators to fast-track its development to becoming a first-line treatment.

The US Food & Drug Administration gave the breakthrough therapy designation for GSK's Bexsero meningococcal group-B vaccine for the development of the vaccine in the prevention of invasive meningitis caused by serogroup B in children 2-10 years of age.

In 2014 Bexsero received BTD for development in the prevention of meningitis in those aged 10-25 years and was subsequently given accelerated approval in January 2015, and is now licensed in more than 35 countries, including members of the European Union and European Economic Area, Australia, Argentina, Chile, Uruguay, Canada and Brazil. GSK said it was the first vaccine in the world to receive the breakthrough designation twice.

With more than a third of all meningitis B cases in the US occurring in children under 11 years old, Dr Thomas Breuer, chief medical officer of GSK's vaccines business, said gaining the designation was "an important step forward in meningococcal prevention and extending the protection provided by this vaccine to a vulnerable age group in the US".

The company's chief vaccines scientist Rino Rappuoli, who has spent more than 20 years developing Bexsero, said: "This designation emphasises the importance of tackling big scientific challenges like meningitis B and breaking new ground in disease prevention through approaches like reverse vaccinology."

Breakthrough therapy designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoins.

With the designation, Bexsero is eligible for all features of the FDA's Fast Track programme, including more frequent communication with the regulator about the drug's development plan and eligibility for accelerated approval and a priority review, if relevant criteria are met.

The news was an extra boost for Britain's biggest pharmaceuticals group ahead of the publication of its full year results at midday on Wednesday, with the results under the microscopeafter the shares lost a quarter of their value since last year's summer highs.

Glaxo's shares were up 0.55% to 1,249.6p at 1035 GMT on Wednesday.