Johnson & Johnson won U.S. approval to sell the antipsychotic drug Caplyta as a treatment for depression, the company said Thursday, a major step in the drugmaker’s efforts to make the medicine a blockbuster.
Caplyta, acquired in J&J’s $14.6 billion deal for Intra-Cellular Therapies earlier this year, is now cleared for the roughly 22 million people in the U.S. with major depressive disorder. That marks the fourth approved use for Caplyta, which J&J has called a potential “wonder pill” that could bring in more than $5 billion in annual sales if it proves effective in more and more psychiatric conditions.
In two pivotal studies, adding Caplyta to standard therapy significantly improved symptoms of depression compared to placebo, reducing patients’ scores on a commonly used measure by 4.9 points and and 4.5 points over six weeks. The four other antipsychotics approved for major depressive disorder — Seroquel XR, Abilify, Rexulti, and Vraylar — demonstrated improvements ranging from 0.9 points to 3.2 points over six weeks in their respective studies.
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