GlaxoSmithKline seeks approval by EU regulator for RTS,S malaria vaccine

GlaxoSmithKline announced Thursday that it applied to the European Medicines Agency (EMA) to market its malaria vaccine candidate RTS,S. Sophie Biernaux, head of the company's malaria vaccine franchise, commented that the submission "brings us a step closer to making available the world's first vaccine that can help protect children in Africa from malaria."

According to GlaxoSmithKline, the filing follows a procedure allowing the EMA to evaluate applications for vaccines and drugs manufactured in Europe for diseases the World Health Organization recognises as being of major interest to public health, but which are intended exclusively for use outside the EU. The drugmaker noted that if the regulator grants a positive opinion on the vaccine, the WHO has indicated that a policy recommendation may be possible by the end of 2015.

GlaxoSmithKline said that RTS,S, which contains the AS01 adjuvant system, is intended for use against the Plasmodium falciparum malaria parasite prevalent in sub-Saharan Africa. The company added that a positive EMA opinion would form the basis of marketing applications to regulatory agencies in sub-Saharan African countries, possibly leading to "the large-scale implementation of the vaccine through... national immunisation programmes."

Last October, GlaxoSmithKline reported updated results from a Phase III trial of RTS,S, with data over 18 months of follow-up demonstrating that the vaccine nearly halved the number of malaria cases in young children and also reduced the number of cases in infants by about a quarter. The company noted that data from the late-stage programme, which was conducted in eight African countries and involved over 16 000 infants and young children, were included to support its filing.

If approved, GlaxoSmithKline said the price of RTS,S will cover the cost of manufacturing and offer the company a return of around 5 percent that will be reinvested in research for second-generation malaria vaccines, or immunisations against other neglected tropical diseases. The company, which has developed RTS,S with the PATH Malaria Vaccine Initiative, has invested more than $350 million to date and expects to spend a further $260 million until development of the vaccine is completed.

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