テバ製薬は、WELTRUZA™のFDA承認を受けています。WELTRUZA™は、成人の精神分裂病の治療に使用される、月1回の皮下長作用注射剤（LAI）のオランzapine製剤であり、ローディング dose、経口補助、または注射後のモニタリングが不要な初めての製品です。
なぜ重要か. 精神分裂症の患者は、従来の治療法に加えてより便利な新しい治療オプションを持つようになりました。これは、服薬の遵守を改善し、長期的な症状管理を支援する可能性があります。
For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (WELTRUZA) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.
Injection site reactions, including hardness, pain, redness, itching, and swelling, were reported with WELTRUZA.
WELTRUZA is injected under the skin (subcutaneously).
WELTRUZA passes into breast milk.
“This approval reflects the strength of patient-centric innovation at Teva and what our R&D organization can deliver,”
For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI (WELTRUZA) treatment groups, while patients who completed period one on active olanzapine LAI (WELTRUZA) remained on their est…
In the coming weeks, WELTRUZA will be available in three different strengths (318 mg, 425 mg, 531 mg)
It is not known whether PDSS can happen with WELTRUZA.
WELTRUZA was developed to address this significant unmet need by offering the established efficacy of olanzapine in a once-monthly subcutaneous injectable formulation.
2.1 million people in the U.S. are currently diagnosed with the condition.
SOLARIS was an 8 week, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-6…
that correspond to the approved daily dose range of oral olanzapine of 10 mg, 15 mg and 20 mg, respectively.
TEV-‘749 is not approved by the EMA at this time.
An estimated 2.1 million people are currently diagnosed with schizophrenia in the U.S.
WELTRUZA is not for the treatment of people with dementia-related psychosis.
Approximately 80% of patients experience multiple relapses over the first five years of treatment
WELTRUZA<sup>™</sup> (olanzapine) for extended-release injectable suspension is a prescription medicine used in adults for the treatment of schizophrenia.
Approximately 1% of the world’s population will develop schizophrenia in their lifetime
WELTRUZA may harm your unborn baby.
WELTRUZA will be available in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg
