The U.S. Food and Drug Administration has granted priority
review to Johnson & Johnson's new drug application for its
schizophrenia treatment, which the company says is the longest
dosing interval available for patients with the condition.
Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson,
has developed the atypical antipsychotic Invega Trinza. The
companies said that patients must first be treated with Invega
Sustenna, a once-monthly injection, for at least four months before
undergoing treatment with Invega Trinza.
Invega Trinza is a three-month injection administered four times
a year. "With a dosing interval that can be measured in seasons,
not days, people living with schizophrenia and their treatment
teams can focus on recovery goals beyond short-term symptom
control," said Dr. Joseph Kwentus in the company's news
release.
According to the companies, 93% of patients in a long-term
maintenance trial treated with Invega Trinza didn't experience a
significant return of schizophrenia symptoms. The results of the
study were published in March.
The FDA grants priority review to drugs that, if approved, would
offer significant improvement in the treatment of serious
conditions. The designation potentially cuts the FDA decision time
to six months from the standard 10 months.
The treatable mental disorder affects more than 21 million
people world-wide, and one in two people living with the condition
does not receive care, according to the World Health
Organization.
Write to Lisa Beilfuss at lisa.beilfuss@wsj.com
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