MedImmune’s Respiratory Syncytial Virus Candidate Receives Fast Track Status from the FDA

Today, AstraZeneca’s biologics arm MedImmune announced that US health regulators have granted fast track designation for its respiratory syncytial virus (RSV) candidate.

The company said that the US Food and Drug Administration (FDA) has granted Fast Track status for the development of MEDI8897, a high-potency, extended half-life monoclonal antibody (mAb). The drug is being evaluated for the prevention of lower respiratory tract illness (LRTI) caused by RSV in infants and young children. The fast track status provides the drug with an expedited development and review timeline, intended for drugs that treat serious conditions and fill an unmet medical need.

RSV is the most prevalent cause of lower respiratory tract infections among infants and young children, resulting in annual epidemics worldwide. In children under the age of one, RSV is the most common cause of bronchiolitis, an inflammation of the small airways in the lung, and pneumonia, and infection of the lungs. Severe RSV causes approximately 125,000 hospitalizations and up to 400 infant deaths each year in the US alone. Currently, no treatment exists for RSV once it is contracted and there is no approved preventative therapy for healthy individuals.

MedImmune has already discovered, developed and currently markets a monoclonal antibody for severe RSV disease. The company hopes to increase the number of infants who are protected from LRTI caused by RSV through its development of MEDI8897 for the passive immunization of all infants, term and preterm.

“While the burden and seriousness of RSV disease has kept it a global priority for vaccine development for more than 50 years, it is well recognized that a significant unmet medical need continues to exist for the prevention of RSV in all infants worldwide,” said Steve Projan, PhD, FAAM, Senior Vice President, R&D and Infectious Diseases & Vaccines Innovative Medicines Unit Head, MedImmune. “We are working with a sense of urgency to develop a next-generation RSV mAb that we believe has the potential to benefit hundreds of thousands more infants, both in the U.S. and around the world. If successful, the fast track designation will enable us to more quickly deliver a preventative solution.”

MedImmune is applying its proprietary technology as part of its development program. The technology aims to increase the half-life of MEDI8897, so that only one dose will be needed for the entire RSV season. In preclinical and in vitro studies, the drug exhibited potent antiviral activity against various RSV A and B clinical isolates, demonstrating broad-spectrum antiviral activity against RSV. The drug is currently being tested in a Phase I study to evaluate the safety, tolerability and pharmacokinetics of the antibody in healthy adults. Based on an analysis of interim data from this study, a separate Phase Ib/IIa study has been initiated to examine MEDI8897 in healthy preterm infants.

Source: MedImmune

Last updated: 4/9/15; 10:05am EST

 

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