AstraZeneca's MedImmune gets RSV candidate fast-tracked

The respiratory syncytial virus (RSV)--Courtesy of NIAID

Two Maryland-based companies are racing to get a vaccine for respiratory syncytial virus (RSV) to market--and one just picked up a regulatory boost.

MedImmune, AstraZeneca's ($AZN) biologics research and development arm, announced on Thursday that the FDA is fast-tracking its RSV vaccine, MEDI8897. It joins Novavax ($NVAX), which received FDA fast-track designation for its candidate in November.

According to the CDC, each year, RSV, for which there is no vaccine and no specific treatment, leads to more than 100,000 hospitalizations of children younger than 1 year old and 177,000 hospitalizations and 14,000 deaths in adults older than 65. AstraZeneca markets Synagis, a monoclonal antibody for use in limited cases, which earned $1.1 billion in 2013 sales. The drug is going off patent in October of this year, which makes it all the more important for AstraZeneca to bring a next-gen RSV treatment to market.

RSV vaccines have been a global priority for more than 50 years, said Steve Projan, MedImmune's SVP of R&D and head of the infectious diseases and vaccines unit, in a statement.

"It is well recognized that a significant unmet medical need continues to exist for the prevention of RSV in all infants worldwide," Projan said. "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's candidate is currently in Phase I safety trials involving healthy adults. Based on the analysis of interim data from this study, MedImmune started a separate Phase 1b/2a study to investigate the candidate in healthy preterm infants.

As for Novavax, its RSV F candidate is in a Phase I trial involving children, as well as a Phase II trial with 1,600 adults older than 60 and a Phase II trial enrolling 50 pregnant women.

- here's the release

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