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AbbVie files supplemental New Drug Application with FDA for cariprazine

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AbbVieAbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar) for major depressive disorder (MDD).

FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar I disorder.

In its recent sNDA, AbbVie is attempting to secure approval of the drug as an adjunctive treatment with MDD who receive ongoing antidepressants.

Antidepressants are a cornerstone of treating depression, although experts are divided on the efficacy of antidepressants in general. One study published on InformedHealth.org found that antidepressants at large are roughly 20% more effective than placebo in treating depression.

In the submission, AbbVie included data on cariprazine recipients showing clinical improvements based on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Last year, AbbVie announced that cariprazine met its primary endpoint in the Phase 3 Study 3111-301-001, which involved a statistically significant change from baseline at week six in the MADRS total score in MDD patients. Cariprazine recipients in that study received either 1.5 mg or 3.0 mg of the drug each day. Those who received the smaller dose demonstrated a statistically significant improvement in the MADRS score.

A second Phase 3 clinical trial known as Study 3111-302-001 also showed improvement in depressive symptoms at the same interval but did not reach statistical significance for either 1.5 mg or 3.0 mg doses of the drug.

AbbVie is partnering with Gedeon Richter in developing cariprazine.

LLY shares were down 0.53% to $239.03 in afternoon trading.

Filed Under: Psychiatric/psychotropic drugs
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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