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An independent panel of cardiology clinicians has recommended that Johnson & Johnson's heart failure drug Natrecor be restricted to the sickest hospitalized patients and called for more studies on the drug, including a large-scale clinical trial.
In a seven-page report, the panel advised that Natrecor not be given to patients in regular outpatient visits – a use that has given fuel to sales of the drug.
Natrecor sales reached $384 million last year, according to data from NDCHealth, Atlanta and financial analysts estimate that the drug's sales volume will double this year to nearly $700 million, based on the growing number of clinics administering the treatment.
The report also calls on J&J, which markets the drug through its Scios unit, to launch an educational program for doctors on the appropriate use of Natrecor that is consistent with the panel's findings.
"We accept the panel's recommendations and are pleased the panel endorsed our current and planned development programs," said Scios senior vice president of clinical research and medical affairs Darlene Horton in a statement.
The Advisory Panel, chaired by Dr. Eugene Braunwald of Harvard Medical School, met in Boston on June 8. Prior to the meeting, the panel members reviewed substantial material provided by Scios, including package inserts, communications sent to physicians by Scios, and recent papers.