The FDA has approved Teva Pharmaceuticals’ Weltruza (olanzapine) for extended-release injectable suspension to treat schizophrenia in adults.
Weltruza is the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine, according to an Oct. 9 news release. The treatment requires no loading doses, oral supplementation or post-injection monitoring.
The approval was based on the phase 3 SOLARIS trial, which demonstrated improvement in symptoms, significant reduction in illness severity and improvement in personal and social functioning. Its systemic safety profile was consistent with oral olanzapine.
Weltruza will be available in three strengths — 318 milligrams, 425 milligrams and 531 milligrams — corresponding to oral olanzapine doses of 10 milligrams, 15 milligrams and 20 milligrams, respectively. It will be available in the U.S. in the coming weeks.
