The US Food and Drug Administration has approved Teva’s WELTRUZA™ (olanzapine) extended release injectable suspension, a once monthly subcutaneous long acting injectable for adults with schizophrenia. It is the first and only long acting olanzapine injection given under the skin once a month. Patients need no loading doses, no oral supplementation and no monitoring after each injection. The product will become available in the coming weeks in three strengths: 318 mg, 425 mg and 531 mg. These correspond to the approved daily oral olanzapine doses of 10 mg, 15 mg and 20 mg respectively.
The approval rests on the pivotal Phase 3 SOLARIS trial. It showed improvement in overall symptoms (PANSS), a significant reduction in illness severity (CGI-S) and better personal and social functioning (PSP). The drug’s systemic safety profile matched that of oral olanzapine.
In SOLARIS, all three doses were tolerated to a similar degree. The most commonly reported adverse events were weight gain, drowsiness, headache, constipation and injection site reactions. Weight gain and metabolic changes were seen, in line with oral olanzapine’s systemic safety profile, and included clinically significant weight gain. Discontinuations because of common adverse events were 5 per cent on WELTRUZA and 4 per cent on placebo.
Chris Fox, executive vice president for US commercial and head of the innovative franchise at Teva, said WELTRUZA brings olanzapine’s proven efficacy to an innovative long acting subcutaneous injection, helping close a major, long standing gap in schizophrenia treatment. He said the medicine was developed with patients in mind from the start, and that the milestone supports Teva’s Pivot to Growth strategy.
Olanzapine is the most widely prescribed atypical antipsychotic for schizophrenia in its daily oral form. Teva notes that daily dosing can make it hard to sustain symptom improvement because of adherence problems, which raises the risk of instability and relapse. WELTRUZA was designed to address that need by offering olanzapine’s established efficacy in a once monthly injection.
Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva, said the approval reflects the strength of patient centred innovation at the company. He said WELTRUZA combines proven science with novel formulation work to remove the need for monitoring after each injection, which tackles a significant barrier to treatment.
Christoph Correll, MD, clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, said olanzapine has been a trusted, foundational treatment for more than 30 years, but adherence remains a major barrier to stability, especially for people who rely on daily oral medication. He said that, because the injection reaches therapeutic blood levels without oral cotreatment, loading doses or booster injections, it can empower patients, support their care partners and give clinicians an important new tool.
An estimated 2.1 million people in the US are currently diagnosed with schizophrenia, a chronic, progressive and severely debilitating mental disorder that affects how a person thinks, feels and behaves. Treatment may require switching from oral options, or between long acting injectables, over time.
WELTRUZA uses SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled, steady and sustained release of olanzapine.
