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The FDA approved Teva’s once-monthly subcutaneous olanzapine, Weltruza, for adults with schizophrenia. The formulation does not require loading doses or post-injection monitoring, although its label still warns about post-injection delirium/sedation syndrome and other risks.
The FDA has approved Weltruza, a once-monthly subcutaneous form of olanzapine, for adults with schizophrenia, Teva Pharmaceuticals announced October 9. The formulation does not require loading doses or routine monitoring for post-injection delirium/sedation syndrome (PDSS), a complication that has limited use of another long-acting olanzapine product.
Weltruza is a long-acting injectable version of olanzapine, an antipsychotic that has been used for decades and is widely prescribed in oral form. Teva says it can reach therapeutic blood levels without oral cotreatment, loading doses or booster injections. The product is administered once a month under the skin.
The approved injectable strengths are 318 mg, 425 mg and 531 mg, corresponding to oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively. Approval was supported by the phase III SOLARIS trial. Teva reported that all dose groups performed better than placebo on the trial’s primary measure, the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week eight. The placebo-adjusted differences ranged from 9.71 to 11.27 points, with P<0.001 for each comparison.
Teva also reported advantages over placebo on two secondary measures: the Clinical Global Impressions-Schizophrenia scale and the Personal and Social Performance Scale. No PDSS cases occurred in the trial, according to the company’s account of the study. The source report does not provide the full trial results or detail how many people participated, so the figures here reflect the reported findings rather than a complete assessment of the evidence.
A Monthly Option Without Routine Observation
For people who have difficulty taking a medication every day, a monthly injection offers a less frequent dosing schedule. Teva’s announcement and the clinician quoted in its release frame adherence as a challenge for some people using daily oral medication; the approval adds another treatment format for clinicians and patients to discuss.
The monitoring difference is relevant because the older long-acting olanzapine product, Zyprexa Relprevv, requires a risk evaluation and mitigation strategy program and three hours of observation after each injection because of PDSS risk. Weltruza does not require that routine observation under its reported approval conditions. That may reduce a practical barrier to receiving injectable olanzapine, but it does not mean the treatment is free of risk or that it will suit every patient.
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How Weltruza Differs From Earlier Injections
Olanzapine is an established antipsychotic available in oral form, but taking a tablet daily can be difficult for some patients. Long-acting injectable medicines are designed to reduce how often a dose must be taken. Earlier injectable olanzapine products have carried a specific concern: post-injection delirium/sedation syndrome, associated with symptoms such as agitation, anxiety and confusion in the hours after treatment.
The reported Weltruza trial findings included no observed PDSS cases, but the product’s FDA labeling still lists PDSS among its warnings and precautions. The label also includes a boxed warning about increased mortality in elderly patients with dementia-related psychosis, a warning shared by antipsychotic drugs. Its listed potential risks include metabolic changes, tardive dyskinesia, neuroleptic malignant syndrome, seizures and orthostatic hypotension, among others.
In SOLARIS, the safety profile was described as generally consistent with oral olanzapine. Reported common adverse events included weight gain, sleepiness, headache and constipation. Injection-site reactions included hardening, pain, redness, itching and swelling.
““Adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications.””
— Christoph Correll, MD, of the Zucker School of Medicine at Hofstra/Northwell, in Teva’s press release
Trial Scope and Real-World Use
The available report does not give the full SOLARIS trial design, participant numbers, duration of follow-up or complete adverse-event data. It also does not establish whether the lack of PDSS cases in the trial means the risk is absent; the FDA label still includes PDSS in its warnings and precautions.
Teva’s announcement, as described in the report, does not specify when Weltruza will be available to patients, its price, insurance coverage or how it will be used in clinical practice. The approval also does not establish that the monthly injection is more effective than oral olanzapine or other schizophrenia treatments. Those questions depend on evidence and practical information beyond the reported approval and trial results.
Availability and Prescribing Details
The next practical developments are expected to include information from Teva about commercial availability and access, along with further detail on prescribing and administration. Patients and clinicians will need to review the approved labeling, including the PDSS warning and the other listed risks, when considering whether the injection is appropriate.
As use begins, clinicians and patients will also be able to assess how the monthly schedule works outside the trial setting and what monitoring is used in practice. No launch date, price or additional regulatory milestone was provided in the source report.
Key Questions
What did the FDA approve?
The FDA approved Weltruza, Teva’s once-monthly subcutaneous olanzapine formulation, for adults with schizophrenia.
Does Weltruza require three hours of monitoring after an injection?
The reported approval information says Weltruza does not require routine post-injection monitoring for PDSS. The three-hour monitoring requirement described in the source applies to the older product Zyprexa Relprevv. Weltruza’s label still lists PDSS among its warnings and precautions.
What evidence supported the approval?
Approval was supported by the phase III SOLARIS trial. Teva reported that all dose groups outperformed placebo on the PANSS total-score change from baseline to week eight, and that two key secondary measures also favored the treatment.
What side effects were reported?
Reported common events included increased weight, somnolence, headache and constipation. Injection-site reactions included induration, pain, redness, itching and swelling. The labeling also lists other warnings and potential risks.
When will Weltruza be available, and what will it cost?
The source report did not provide an availability date, price or insurance-coverage details. Those points remain unclear based on the information provided.
Source: rss
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