Drugs

FDA Approves Caplyta for Major Depressive Disorder

FDA has approved an expanded use for Johnson & Johnson’s Caplyta (lumateperone) as an adjunctive therapy with oral antidepressants in adults with major depressive disorder. Caplyta was previously approved for schizophrenia and bipolar I and II depression.

Approval was based on data from two global, double-blind, placebo-controlled Phase 3 trials (Study 501 and Study 502), both of which met primary and key secondary endpoints, according to the company. Caplyta, when added to an existing antidepressant, demonstrated statistically significant and clinically meaningful reductions in depression symptoms compared with placebo, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression-Severity (CGI-S) scale, it says. Highlights of study findings include:

In Study 501, MADRS scores improved by -4.9 points (effect size 0.61) versus placebo at six weeks, with separation seen as early as one week.
Study 502 showed a -4.5 point improvement (effect size 0.56), with separation from placebo by week two.
CGI-S scores also improved significantly in both studies at six weeks.

Additionally, Caplyta’s safety and tolerability profile was favorable and consistent with previous studies in schizophrenia and bipolar depression, the company says. Weight gain, metabolic changes, and sexual side effects were similar to placebo. Most common adverse events included sleepiness, dizziness, nausea, dry mouth, fatigue, and diarrhea, it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome