Teva Pharmaceutical Industries Ltd. announced today that its U.S. affiliate, Teva Pharmaceuticals, has received FDA approval for WELTRUZA (olanzapine) extended-release injectable suspension. This new once-monthly, subcutaneous long-acting treatment is indicated for adults diagnosed with schizophrenia.

The recent clinical trial results for WELTRUZA (olanzapine) extended-release injectable suspension demonstrated a measurable improvement in overall symptoms (PANSS), a significant reduction in illness severity (CGI-S), and notable progress in personal and social functioning (PSP).

“WELTRUZA offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape,” said Chris Fox, Executive Vice President, U.S. Commercial and Head of Innovative Franchise at Teva. “WELTRUZA was developed with the patient in mind from day one and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva’s Pivot to Growth strategy.”

Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia as a daily oral treatment. However, it is well documented that daily options may make it difficult to sustain long-term symptom improvement due to challenges with adherence, increasing the risk for instability and relapse. WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.

“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “WELTRUZA combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia.”

WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.

“Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications,” said Christoph Correll, MD, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY. “By offering a subcutaneous long-acting injectable formulation with achievement of therapeutic blood levels without oral cotreatment, loading doses or booster injections, this new treatment option can help empower patients, support their care partners and provide clinicians with an important new tool to assist in managing this complex condition more effectively.”

In the Phase 3 SOLARIS trial, all three doses of WELTRUZA were similarly tolerated, with the most common reported adverse events (AEs) inclusive of increased weight, somnolence, headache, constipation and injection site reactions.1 Weight gain and metabolic changes were observed and were consistent with the systemic safety profile of oral olanzapine, including clinically significant weight gain.1 Discontinuations of WELTRUZA due to common AEs were consistent with placebo at 5% and 4% of trial participants, respectively.1 Please refer to the Important Safety Information below for additional safety information.