FDA approves Weltruza monthly subcutaneous olanzapine injection

The FDA has approved Weltruza, a once-monthly subcutaneous long-acting injectable (LAI) olanzapine for treating schizophrenia in adults. Developed by Teva Pharmaceuticals using polymer technology from Medincell, the treatment is designed to eliminate the need for loading doses, oral supplementation, or post-injection monitoring.

This new formulation addresses adherence challenges in schizophrenia treatment, where approximately half of patients struggle with medication consistency. Unlike the existing intramuscular formulation, Zyprexa Relprevv, which requires patients to be monitored at a certified facility for at least three hours due to the risk of post-injection delirium/sedation syndrome (PDSS), Weltruza does not require post-injection observation.

Weltruza will be available in the United States in the coming weeks in three strengths: 318 mg, 425 mg, and 531 mg. These doses correspond to daily oral olanzapine doses of 10 mg, 15 mg, and 20 mg, respectively.