New data support GSK plan to file for approval of malaria vaccine in 2014
Results from a large-scale Phase III trial, presented today (October 8) at the Multilateral Initiative on Malaria Pan African Conference in Durban, South Africa, show that the most clinically advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination.
Based on these data, UK pharma giant GlaxoSmithKline (LSE: GSK) now intends to submit, in 2014, a regulatory application to the European Medicines Agency. The World Health Organization has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by the EMA.
GSK said it had invested more than $350 million in RTS,S "and expects to invest more than $260 million until development is completed."
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