Latuda Granted New Indication
March 6, 2018 – The U.S. FDA has approved a new indication for Sunovion Pharmaceuticals’ Latuda® (lurasidone HCl). The drug may now be used to treat major depressive episodes in pediatric patients who are at least 10 years old and have bipolar I disorder.
Bipolar disorder affects an estimated 12.6 million people in the United States, with at least half of patients experiencing symptoms before the age of 18. A chronic behavioral health condition, bipolar disorder is characterized by unusual changes in mood, energy, activity, and the ability to complete day-to-day tasks. Individuals diagnosed with bipolar I disorder experience manic episodes lasting for a minimum of seven days or that require immediate hospital care, and typically endure depressive episodes lasting for at least two weeks. In some instances, patients may experience symptoms of depression and mania concurrently.
Treatment options for pediatric patients with bipolar I disorder are often limited. Left untreated, bipolar I disorder can contribute to poor progress in school, and impair social interaction. The FDA based approval for Latuda’s new indication on a clinical study in which children ages 10 to 17 experienced meaningful improvement in symptoms of bipolar depression on Latuda compared to those who received a placebo.
Latuda is also approved as a monotherapy for treatment of adults with bipolar disorder who experience depressive episodes, and for adolescents and adults diagnosed with schizophrenia. It carries a black box warning to indicate that it should not be used in elderly patients with dementia, due to increased risk of death, and that use of antidepressants by pediatric and young adult patients may cause suicidal thoughts or behavior.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.