Johnson & Johnson’s Newly Acquired Antipsychotic Drug Approved By FDA For Major Depressive Disorder

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JNJ gained access to Caplyta with the $14.6 billion acquisition of Intra-Cellular Therapies, Inc., which closed in April.

  • The new approval is the first for the drug under JNJ leadership. 
  • The drug is also approved for the treatment of bipolar I and II depression as well as schizophrenia in adults.
  • JNJ recently submitted a new application for Caplyta to the FDA with data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia.

Johnson & Johnson (JNJ) said on Thursday that the U.S. Food and Drug Administration (FDA) has approved its antipsychotic Caplyta in the treatment of major depressive disorder in adults in combination with antidepressants.

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JNJ gained access to Caplyta with the $14.6 billion acquisition of Intra-Cellular Therapies, Inc., which closed in April. The new approval is the first for the drug under JNJ leadership.

The New Approval

Caplyta is also approved for the treatment of bipolar I and II depression as well as schizophrenia in adults.

According to the drug maker, major depressive disorder is one of the most common psychiatric disorders, affecting about 22 million American adults. The drug’s new approval is based on results from two late-stage trials where statistically significant and clinically meaningful improvement in depression symptoms were observed when Caplyta was combined with an antidepressant as compared to an oral antidepressant plus placebo.

The drug’s safety profile in the studies was consistent with previous studies, and no new safety concerns were identified, it added.

JNJ recently submitted a new application for Caplyta to the FDA with data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia. It is also being studied for other neuropsychiatric and neurological disorders.

In the third quarter, JNJ reported sales of $240 million from the drug.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around JNJ stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels.

JNJ stock is up by 28% this year and by about 18% over the past 12 months. 

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