Biopharmaceutical company AstraZeneca Plc (LON:AZN) and its global biologics research and development arm, MedImmune, announced on Tuesday the grant by the European Medicines Agency (EMA) of access to its PRIME (PRIority MEdicines) scheme 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.

This PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimise development plans and accelerate evaluation so these medicines can reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.

According to the company, it will work closely with the European Medicines Agency to optimise its development plan and help it bring MEDI8897 to patients as quickly as possible.

Reportedly, this is the first EMA PRIME eligibility that AstraZeneca has received since the programme's initiation. It 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.

Also, the development programme for MEDI8897 also includes a phase III trial in late preterm and healthy full-term infants. AstraZeneca will also conduct a phase II/III study in Synagis-eligible paediatric patients to generate additional data for use in this population.

In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialise MEDI8897 jointly. In November 2018, AstraZeneca announced 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.