Global, science-led biopharmaceutical company AstraZeneca Plc (LON:AZN) and its global biologics research and development arm, MedImmune, announced on Tuesday the grant by the US Food and Drug Administration (FDA) of Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

The company stated that a BTD is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines.

MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the US FDA in March 2015.

According to the company, this Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help it to bring MEDI8897 to all infants at risk for RSV as quickly as possible.

This BTD is based on the primary analysis of the phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint defined as a 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. Full results from the phase IIb trial will be presented at a forthcoming medical meeting.

In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialise MEDI8897 jointly. In November 2018, AstraZeneca announced that Swedish Orphan Biovitrum AB has the right to participate in payments that may be received from the US profits or losses for MEDI8897.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.