The U.S. Food and Drug Administration (FDA) recently approved Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to market Weltruza, a once-monthly subcutaneous injectable for adult patients with schizophrenia.
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“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.
“This important milestone also helps further Teva’s Pivot to Growth strategy,” Fox further commented.
FDA Approves New Schizophrenia Treatment
While doctors widely prescribe oral olanzapine to treat schizophrenia, daily pills often cause adherence issues that increase patient instability and relapse risks. Weltruza solves this problem by delivering a steady dose of the medication.
The drug utilizes SteadyTeq, a proprietary copolymer technology developed by Medincell, to ensure sustained release.
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Clinical Success and Availability
In the Phase 3 SOLARIS trial, patients taking Weltruza experienced significant reductions in illness severity and notable improvements in both symptoms and social functioning. Participants tolerated all three available doses well.
The company will launch the medication in the U.S. in the coming weeks to help treat the estimated 2.1 million Americans diagnosed with the condition. It will come in 318 mg, 425 mg, and 531 mg strengths, which match standard daily oral amounts.
Patients will not require loading doses, oral supplements, or post-injection monitoring.
European Expansion Plans
Looking ahead, the European Medicines Agency accepted the marketing application for the long-acting injectable in May 2026, backed by the extensive SOLARIS clinical program.
TEVA Price Action: Teva Pharmaceutical shares were up 6.17% at $41.67 at the time of publication on Friday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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