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Regulator approves P3 trials for RSV treatment with extended half-life

Lee Hye-seon  Published 2019.07.23  11:08  Updated 2019.07.23 16:56

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Phase 3 clinical trials of Nirsevimab, a treatment for the respiratory syncytial virus (RSV), which causes acute respiratory infections among infants, will be conducted in Korea.

The Ministry of Food and Drug Safety approved the phase 3 clinical trial of “MEDI8897 Inj.” on Friday. The drug is a treatment for lower respiratory tract infection caused by RSV.

RSV is a virus that causes bronchiolitis and pneumonia in infants younger than 36 months and requires hospitalization of the patients as symptoms include cough, sputum, fever, and difficulty in breathing.

Currently, the standard therapy is a product called Synagis (ingredient: palivizumab), which injects an antibody against RSV into the body. However, the treatment only has a half-life of about 30 days, which, in turn, requires patients to receive the drug monthly when the illness is prevalent from October to March.

The drug is already expensive, forcing doctors to administer it only on premature babies 35 weeks older or less, and babies and infants with lung or heart diseases.

MEDI8897 is a treatment that increased the half-life so that patients only have to receive the medicine only once in five months.

The phase 3 clinical trial is a multinational, randomized, double-blind, placebo-controlled research aimed at evaluating the safety and efficacy of MEDI8897, a monoclonal antibody with extended half-life to RSV in healthy preterm and term infants.

About 3,000 infants will participate in the trial, including 34 infants from Korea. Participating hospitals include Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Asan Medical Center, Chungnam National University Hospital, Hanyang University Seoul Hospital, Ajou University Hospital, and Inha University Hospital.

MEDI8897 was jointly developed by AstraZeneca and Sanofi Pasteur and received breakthrough therapy designation from the U.S. Food and Drug Administration in February.

lhs@docdocdoc.co.kr

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