AstraZeneca scores accelerated approval in US and Europe for respiratory syncytial virus drug
pharmafile | February 5, 2019 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | AstraZeneca, EMA, FDA, MEDI8897, pharma, respiratory syncytial virus
It’s a double victory for AstraZeneca as the company announced its F monoclonal antibody MEDI8897 has been granted accelerated review by both the EMA and the FDA for the prevention of lower respiratory tract infection (LRTI) as a result of respiratory syncytial virus (RSV).
In Europe, AstraZeneca’s drug, which I sbeing developed in partnership with Sanofi Pasteur, was accepted onto the EMA’s priority review scheme PRIME, marking the company’s first ever receipt of such eligibility. The designation means that MEDI8897 will see its review process shortened with the goal of getting the drug to patients earlier.
MEDI8897 secured this eligibility off the back of primary analysis of Phase 2b data in which showed that the drug met its primary endpoint of statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV for 150 days after dosing in healthy preterm infants.
On the other side of the Atlantic, the drug was awarded breakthrough therapy designation (BTD) by the FDA for the same indication, once again thanks to the same Phase 2b data, which in a similar way means that will it see an accelerated review process. The treatment was originally awarded Fast Track designation in 2015.
“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,” commented AstraZeneca’s Mene Pangalos, Executive Vice-President, 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.”
Matt Fellows
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
LGC Group opens $100M Organic Chemistry Synthesis Centre of Excellence
LGC Group, a life sciences company, has opened its new Organic Chemistry Synthesis Centre of …
