AstraZeneca’s MEDI8897 has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV).
MEDI8897, which is a single dose extended half-life anti-RSV F monoclonal antibody (mAb), is being developed jointly by AstraZeneca’s biologics research and development arm MedImmune and Sanofi Pasteur.
The BTD for the anti-RSV F mAb follows the fast track designation it received from the FDA in March 2015.
The latest designation was driven by the primary analysis of a Phase IIb trial that assessed the safety and efficacy of MEDI8897.
The mid-stage trial met its primary endpoint, which is a statistically-significant reduction in the incidence of medically-attended LRTI resulting from reverse transcriptase polymerase chain reaction-confirmed RSV, for 150 days following dosing in healthy preterm infants.
The BTD is expected to expedite the development and regulatory review of MEDI8897. It was granted by the regulator as it is being developed for the treatment of a serious condition and has yielded promising early clinical results among other factors.
In another development, the European Medicines Agency (EMA) has granted access to its PRIority MEdicines (PRIME) scheme for MEDI8897 based on the primary analysis of the same phase IIb trial.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.
“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.”
MEDI8897 is being developed for the prevention of LRTI caused by RSV in all infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season.
Last month, AstraZeneca completed the sale of its US rights of its respiratory drug Synagis (palivizumab) to Swedish Orphan Biovitrum AB (Sobi) in a deal worth around $1.6bn. Under the same deal, the Swedish pharma company was granted the right to take part in AstraZeneca’s share of US profits and losses associated with MEDI8897.