Johnson & Johnson Submits Supplemental Drug Application To FDA For Schizophrenia Drug Caplyta

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug Administration based on data evaluating the efficacy of its oral drug Caplyta in preventing relapse in schizophrenia.

Caplyta is the newest addition to Johnson & Johnson’s portfolio of schizophrenia therapies. It is approved by the FDA to treat schizophrenia as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate.

J&J gained access to Caplyta by the acquisition of Intra-Cellular Therapies, Inc. which was completed in April.

A Supplemental New Drug Application (sNDA) is a submission to the FDA for changes to an already approved New Drug Application (NDA), including the addition of new uses.

The new application is based on data from a late-stage study demonstrating that treatment with Caplyta was associated with a 63% reduction in the risk of relapse in adults with schizophrenia compared to placebo.

Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States but is largely insufficiently treated, J&J said. While symptoms of schizophrenia vary from person to person, confusion and distortions in perceptions, emotions, and behavior are common, the company added.

When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors. On average, an adult with schizophrenia experiences nine relapses in less than six years, the company noted.

On Stocktwits, retail sentiment around JNJ is trending in the ‘bullish’ territory over the past 24 hours, coupled with ‘high’ message volume.

JNJ stock is up by over 7% this year and by nearly 7% over the past 12 months.

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