J&J's Janssen Gets FDA Breakthrough Therapy Designation for RSV Vaccine in Older Adults

By Colin Kellaher

Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit on Tuesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation for its investigational vaccine for the prevention of respiratory syncytial virus in adults at least 60 years of age.

Janssen said there are no preventive vaccines or effective antiviral treatments currently available for RSV, a highly-contagious, potentially life-threatening respiratory infection that affects more than 64 million people a year.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Janssen said older adults are among those at highest risk of developing RSV. The company said its investigational vaccine is currently in a phase 2b proof-of-concept study in adults who are at least 65 years old.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 03, 2019 10:29 ET (14:29 GMT)

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