Teva Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for WELTRUZA™ (olanzapine) extended-release injectable suspension, a once-monthly subcutaneous treatment for adults with schizophrenia. According to the company, Weltruza is the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine approved for this indication in the United States.
The approval introduces a new delivery option for olanzapine, an established atypical antipsychotic used to manage schizophrenia. Unlike daily oral treatment, Weltruza is designed to provide sustained drug release through a monthly injection under the skin, potentially reducing the burden of daily medication and addressing challenges associated with treatment adherence.
The FDA approval is supported by results from the Phase 3 SOLARIS clinical trial, which evaluated the efficacy, safety and tolerability of extended-release subcutaneous olanzapine in adults with schizophrenia.
The trial’s initial eight-week phase enrolled 675 patients aged 18–64 years, who were assigned to receive one of three Weltruza doses or placebo. The subsequent 48-week phase evaluated continued treatment and safety. The findings supported the medicine’s clinical development and regulatory approval, according to Teva.
Teva states that the treatment does not require loading doses, additional oral olanzapine supplementation or routine post-injection monitoring. These features may simplify treatment logistics for patients, caregivers and healthcare professionals.
The formulation uses SteadyTeq™, a proprietary copolymer technology developed by Medincell to provide controlled, sustained release of olanzapine.
Weltruza is expected to be available in the United States in three strengths: 318 mg, 425 mg and 531 mg. These correspond to daily oral olanzapine dose ranges of 10 mg, 15 mg and 20 mg, respectively, according to the company.
Claims such as “first and only” come from Tevapharmaceuticals press release.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
