Teva's Once-Monthly Schizophrenia Shot Enters EMA Review, Signaling New Treatment Option
Decision brief
Answer first · skim in under a minute
The European Medicines Agency (EMA) has accepted Teva Pharmaceuticals and Medincell's marketing authorization application for their once-monthly olanzapine long-acting injectable (LAI) for the treatment of schizophrenia in adults. This regulatory milestone signifies a potential new adherence-focused treatment option for patients in Europe.
EMA has accepted Teva and Medincell’s marketing authorization application for once-monthly subcutaneous olanzapine long-acting injectable TEV-749 for adults with schizophrenia, moving the adherence-focused LAI into CHMP scientific review after the companies’ 21 May 2026 GlobeNewswire announcement.
Contents9 sections
Key Takeaways
- EMA accepted the MAA for olanzapine LAI TEV-749 on 21 May 2026 (Teva/Medincell GlobeNewswire).
- Dosing design: subcutaneous injection every four weeks; not approved anywhere yet.
- Clinical backbone: Phase 3 SOLARIS (NCT05693935 / TV44749-CNS-30096).
- FDA previously accepted an NDA for the same asset (announced 20 February 2026).
What exactly entered EMA review?
According to the 21 May 2026 GlobeNewswire release, EMA accepted the MAA for olanzapine LAI (TEV-749) for schizophrenia in adults.
The product is designed to deliver olanzapine efficacy as a subcutaneous injection every four weeks. Teva Pharmaceuticals International GmbH filed with Medincell; the companies state TEV-749 is not approved by any regulatory authority worldwide at this time.
What does SOLARIS contribute to the olanzapine file?
SOLARIS is registered on ClinicalTrials.gov as NCT05693935, officially evaluating olanzapine for extended-release injectable suspension (TV-44749) for subcutaneous use in adults with schizophrenia.
Teva’s GlobeNewswire filing note says the EMA submission is supported by an extensive development programme including Phase 3 SOLARIS, with efficacy, systemic safety, and exposure described as consistent with oral olanzapine. A September 2025 long-term safety update reported no PDSS events across 3,470 injections through Week 56 in integrated double-blind and open-label periods.
How should EU commercial teams time the opportunity?
MAA acceptance starts CHMP assessment; it is not approval. Standard centralised review runs on the order of 210 active days before clock-stops, so a CHMP opinion is more likely in 2027 than in 2026 unless accelerated assessment applies—and Teva has not publicly confirmed accelerated status in the May 2026 wire.
- Watch for CHMP list-of-questions and any REMS-like EU risk-management commitments.
- Model launch economics against oral olanzapine generics and existing LAIs.
- Track US NDA timing in parallel after the February 2026 FDA acceptance wire.
What remains unproven?
Label language, post-injection monitoring requirements in the EU, and comparative effectiveness versus other LAIs are not settled by MAA acceptance alone. PDSS claims rest on clinical-programme observations reported by the sponsor and still require regulator endorsement.
Related NovaPharma reading includes EMA’s new EU pharma rules implementation, CHMP approvals analysis, and the diseases hub.
Why does once-monthly olanzapine matter clinically?
Oral olanzapine is widely used, but daily adherence remains a relapse risk. A subcutaneous monthly LAI without a facility-monitoring REMS—if ultimately labelled that way—would address a formulation gap sponsors have highlighted for years. Until CHMP and the European Commission finish, that remains a pipeline thesis, not a marketed claim.
Related NovaPharma coverage
- EMA implements new EU pharmaceutical legislation
- Regeneron EMA eye drug review
- ASCO 2026 AstraZeneca and Roche
Frequently Asked Questions
What did EMA accept for Teva’s olanzapine LAI?
On 21 May 2026, Teva and Medincell announced via GlobeNewswire that the European Medicines Agency accepted a Marketing Authorization Application for olanzapine long-acting injectable TEV-749, a once-every-four-weeks subcutaneous formulation for schizophrenia in adults. The product is not approved by any regulator worldwide.
What clinical evidence supports the olanzapine LAI filing?
The EMA submission is supported by the Phase 3 SOLARIS programme (NCT05693935), which evaluated TV-44749 (TEV-749) in adults with schizophrenia. Sponsor communications state efficacy, systemic safety, and exposure consistent with oral olanzapine across clinical development, including long-term safety analyses reporting no PDSS events among 3,470 injections through Week 56.
How does the US filing status compare?
Separately, Teva and Medincell announced on 20 February 2026 that FDA accepted an NDA for the same once-monthly subcutaneous olanzapine extended-release injectable suspension (TEV-749) for adults with schizophrenia, positioning EU MAA acceptance as a parallel regional milestone rather than the first filing.
Primary Sources
Regulatory catalyst tracker
Track PDUFA dates, approval milestones, and label updates for olanzapine.
Unlock full calendar →Teva pipeline snapshot
One-screen view of active programs, phases, and recent catalysts from public sources.
Investor brief
Download a one-page summary of regulatory impact and competitive context.
Explore drug hub →Entity graph
Continue Exploring
Open the drugs, companies, and topics behind this story.
Sources & references 1 primary sources
Sources verified at publication. See our editorial policy and data sources.
This article follows our editorial standards. Report a correction via editorial contact.
