Regulator grants Astra Zeneca's MEDI8897 PRIME status

European regulators have approved the inclusion of AstraZeneca's treatment for respiratory syncytial virus, a common lung ailment in children, in its accelerated approval programme for "promising" medicines.

The European Medicines Agency has granted the firm's MEDI8897 treatment access to its PRIME scheme for so-called 'priority medicines', which helps companies optimise their development plans and accelerate evaluation so medicines can reach patients faster.

Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals at AstraZeneca, hailed the news, saying the company would "work closely with the European Medicines Agency to optimise [its] development plan" and bring the new treatment to market as quickly as possible.

Tuesday's news marked the first such inclusion of AstraZeneca in the EMA's PRIME programme and followed the primary analysis of the Phase IIb clinical trial to evaluate the efficacy of MEDI8897 in helping to prevent lower respiratory tract infections in healthy preterm infants.

The full results of the PhaseIIb trial were scheduled to be presented at a forthcoming medical meeting, the company said in a statement.

Significantly, MEDI8897 was being developed to treat a broader infant population than the current standard of care for RSV prevention, Synagis, which had only been approved for use with high-risk infants.