FDA Approves Teva's Monthly Schizophrenia Injection Weltrusa
Translated & summarized from Ynet by baba
The FDA has approved Teva's Weltrusa, a monthly subcutaneous injection of olanzapine for schizophrenia, aiming to improve patient adherence compared to daily pills. The injection uses a novel formulation that avoids the need for post-injection monitoring, unlike a previous intramuscular option. Clinical trials showed symptom improvement and manageable side effects, though weight gain is a known issue. This approval is significant for Teva's strategic shift towards innovative drugs.
The story in 5 lines · by baba
- The FDA approved Teva's Weltrusa, a monthly subcutaneous injection for schizophrenia treatment.
- Weltrusa uses a new formulation to improve patient adherence over daily olanzapine pills.
- The injection avoids the serious side effect risks associated with a previous intramuscular olanzapine option.
- Clinical trials demonstrated symptom improvement and manageable side effects, including weight gain.
- This approval supports Teva's strategic focus on developing innovative, branded medications.
The U.S. Food and Drug Administration (FDA) has approved Weltrusa (WELTRUZA), a monthly subcutaneous injection of the long-standing drug olanzapine, developed by Teva Pharmaceuticals. Teva states this is the first monthly subcutaneous injection of olanzapine, which has been in use for three decades and is the most prescribed second-generation antipsychotic for schizophrenia. The new formulation aims to address the challenge of daily oral administration, which many patients struggle to adhere to, leading to increased risks of relapse and functional decline.
Weltrusa utilizes Medincell's technology, where polymers in the suspension form a depot under the skin, gradually releasing the drug over a month. Unlike the existing intramuscular injection Zyprexa Relprevv, Weltrusa does not require post-injection monitoring for the rare but serious post-injection delirium/sedation syndrome (PDSS). Teva claims the injection does not necessitate loading doses, supplemental pills, or post-injection observation, a claim supported by their clinical trial data.
The approval was based on the SOLARIS trial, involving 675 adults with schizophrenia. The study showed improvements in disease symptoms, severity, and social functioning with Weltrusa compared to a placebo. Common side effects included weight gain, somnolence, headache, constipation, and injection site reactions. The weight gain and metabolic changes align with olanzapine's known profile.
Dr. Eric Hughes of Teva highlighted Weltrusa's combination of proven science and innovative formulation, addressing a significant treatment barrier. Professor Christoph Correll noted that while olanzapine is a reliable treatment, adherence remains a major hurdle, and Weltrusa offers a new tool for managing the complex illness.
This approval marks a step in Teva's transition towards focusing on innovative drugs. Weltrusa is also under review by the European Medicines Agency (EMA). Meanwhile, another schizophrenia drug, Cobenfy, approved in the U.S. for its novel mechanism targeting acetylcholine receptors, was not included in Israel's 2026 health basket due to budget limitations.
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