Teva Pharmaceuticals has received US FDA approval for WELTRUZA (olanzapine), an extended-release injectable suspension for adults with schizophrenia.
The once-monthly subcutaneous long-acting injectable (LAI) is the first of its kind to deliver olanzapine without requiring loading doses, oral supplementation or post-injection monitoring.
The approval, announced on 9th October, marks the second FDA-approved medicine developed using technology from French biopharma company Medincell, following UZEDY (risperidone), which was approved in 2023.
Teva plans to launch WELTRUZA in the US in the coming weeks, in three strengths: 318 mg, 425 mg and 531 mg.
Controlled-release formulation technology
WELTRUZA uses SteadyTeq, a copolymer technology developed by Medincell that enables the controlled, sustained release of olanzapine following subcutaneous administration.
The formulation is designed to maintain therapeutic drug levels during the course of a month, reducing the need for daily oral dosing.
Medincell specialises in long-acting injectable drug delivery systems, using its proprietary BEPO technology platform to develop formulations that release APIs during days, weeks or even months.
The technology forms a small, bioresorbable polymer depot beneath the skin, from which the drug is gradually released.
The approach could help address treatment adherence challenges associated with daily medication.
According to Teva, olanzapine is widely prescribed as an oral treatment for schizophrenia, but maintaining consistent use can be difficult for some patients, potentially increasing the risk of symptom recurrence.
Phase III trial supports approval
The FDA approval was supported by results from the pivotal Phase III SOLARIS trial.
According to Teva, the study demonstrated improvements in schizophrenia symptoms, reductions in illness severity and improvements in personal and social functioning.
The medicine's systemic safety profile was consistent with oral olanzapine.
Reported adverse events included weight gain, somnolence, headache, constipation and injection-site reactions. However, the weight gain and metabolic changes were consistent with the known safety profile of oral olanzapine.
The approval marks another commercial milestone for Medincell's sustained-release formulation technology.
The company is eligible for mid- to high-single-digit royalties on worldwide net sales of WELTRUZA, alongside potential development and commercial milestone payments of up to $112m.
Meanwhile, a marketing authorisation application for the long-acting olanzapine formulation was accepted by the European Medicines Agency in May this year. The medicine has not yet been approved in the EU.
