Double boost from European and US regulators for AstraZeneca’s lung infection treatment

MEDI8897 is being developed as a treatment for a respiratory syncytial virus – a major cause of lower respiratory tract infection which affects around 90% of children under two

baby coughing
Both BTD and PRIME are designed to speed up the development and approval process for new drugs

AstraZeneca PLC’s (LON:AZN) has been given a double shot in the arm this morning in its bid to bring to market a drug designed to treat a common lung infection in children.

The FTSE 100 group is developing MEDI8897 as a treatment for a respiratory syncytial virus – a major cause of lower respiratory tract infection (LRTI) which affects around 90% of children under two.

READ: Astra’s severe asthma treatment granted BTD

A recent phase IIb trial showed that children treated with the drug were less likely to suffer from LRTI caused by RSV.

Delivering the first bit of good news was the US Food and Drug Administration which granted the treatment breakthrough therapy designation.

A BTD is designed to expedite the development and review of medicines that are intended to treat a serious and have shown promise in early-stage clinical trials.

On top of that, MEDI8897 has also been granted access to PRIME – an initiative launched by the European Medicines Agency back in 2016 which is also designed to accelerate the development of drugs so they can reach patients faster.

EMA give their backing

To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.

This is the first time that any of Astra’s drugs have received PRIME eligibility since the initiative’s inception.

“MEDI8897 is our next-generation preventive medicine for respiratory syncytial virus, which has the potential to address an important unmet need for infants, families and caregivers,” said Mene Panaglos, AstraZeneca’s executive vice president of R&D BioPharmaceuticals.

“The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible.”

AstraZeneca shares edged 7p higher to 5,575p early on Tuesday.

Quick facts: AstraZeneca

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