Prevention of respiratory package virus (RSV)! FDA grants AstraZeneta a breakthrough drug for next-generation antibody MEDI8897:

British pharmaceutical giant AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has awarded MEDI8897 Breakthrough Treatment Designation (BTD), a half-life-extending respiratory syncytial virus (RSV) fusion (F) protein monoclonal antibody (Mab) that is being developed to prevent lower respiratory infection (LRTI) caused by RSV. In March 2015, MEDI8897 was also granted fast-track eligibility by the FDA.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments. Access to BTD drugs can be developed with closer guidance, including from senior FDA officials, including scientific contacts to help speed up review times and eligibility for accelerated approval, as well as priority reviews after meeting relevant standards, to ensure that new treatment options are available to patients in the shortest possible time.
"MEDI8897 is the company's next-generation respiratory syncytial virus prevention drug that has the potential to address the important needs of infants, families and caregivers," said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZenecon. FDA granting the drug BTD will help us accelerate the development of MEDI8897 and bring it to all infants and young children at risk of RSV as soon as possible. The
the FDA to MEDI8897 BTD is based on the preliminary results of a Phase IIb clinical study evaluating the efficacy and safety of MEDI8897. The data showed that the study reached its primary endpoint, defined as a statistically significant reduction in the occurrence of LRTI in medical care caused by reverse transcriptase polymerase chain reaction (RT-PCR) within 150 days of being given in healthy premature children. The full results of the study will be presented at an upcoming medical conference.
, RSV is the most common cause of LRTI in infants and young children, with about 90 percent of children infected with RSV in the first two years of life. Of these, up to 40 per cent experience LRTI at the time of initial infection, making the development and accessability of effective prevention methods an important public health priority. In the United States, there is currently only one approved preventive drug for RSV, Synagis (palivizumab), which is also standard care therapy for RSV prevention, but only for high-risk children (pre-pregnancy≤35 weeks of premature birth, children with chronic lung disease caused by premature lung development, and children with significant hemodynamics.
MEDI8897 is being developed for a wider infant population than Synagis, as well as a long-acting preparation that requires only one injection during a typical five-month RSV season, while Synagis needs one injection per month.
meDI8897 development project also includes a Phase III clinical study in late-stage premature and healthy full-term infants. AstraZeneta will also conduct a Phase II/III study to generate more data for this group of pediatric patients who qualify for Synagis medication.
March 2017, AstraZeneta and Sanofi Pasteur announced an agreement to jointly develop and commercialize MEDI8897. In November 2018, AstraZeneta sold Synagis and MEDI8897's U.S. interests for $2.315 billion (including a $1.5 billion advance plus a milestone of $815 million) to Swedish rare disease drugmaker Swedish Orphan Biovitrum (SOB). (Bio Valley)