Teva Pharmaceutical Receives FDA Approval for Monthly Schizophrenia Injection

Israeli pharmaceutical giant Teva has received approval from the U.S. Food and Drug Administration (FDA) for Weltruza, a new monthly injectable medication for schizophrenia. This innovative treatment offers a significant advantage over daily oral pills, addressing the challenge many patients face with consistent medication adherence. Non-adherence, often due to a lack of insight into their illness, can lead to recurrent psychotic episodes, which Teva states affect approximately 80% of patients within the first five years of treatment and can worsen their condition.

Weltruza is based on olanzapine, a widely used antipsychotic for about 30 years, but utilizes technology from MedinCell. Unlike previous long-acting injectable forms of olanzapine that required three hours of observation post-injection due to a rare but serious side effect of rapid drug absorption, Weltruza forms a subcutaneous reservoir that gradually releases the medication over a month. Teva claims this eliminates the need for additional pills or post-injection observation.

The FDA's approval was based on a study of 675 schizophrenia patients, where Weltruza demonstrated symptom reduction and improved daily functioning. Common side effects included weight gain, drowsiness, headache, constipation, and injection site reactions, with an overall safety profile similar to oral olanzapine. Teva's Chief Medical Officer, Dr. Eric Hughes, highlighted that Weltruza combines olanzapine's efficacy with a novel delivery method, removing the need for post-injection monitoring.

Psychiatrist Christoph Correll noted that adherence, rather than drug efficacy, is often the primary issue for patients, suggesting the monthly injection could greatly benefit patients, their families, and doctors. He clarified that Weltruza represents a new formulation of an existing drug, not a novel mechanism of action, contrasting it with the 2024 FDA-approved Cobenfy from Bristol Myers Squibb, which targets the acetylcholine system. Cobenfy is registered in Israel but was not included in the 2026 subsidized medicine basket due to budget constraints.

Weltruza is currently undergoing registration in Europe, with Teva not yet providing a timeline for its potential availability in Israel. This approval is strategically important for Teva as it continues its focus on developing original, innovative drugs and reducing its reliance on the generic market.