Teva Pharmaceutical Industries Says FDA Approved WELTRUZA for Schizophrenia in Adults

MT Newswires Live10-09 19:36

Teva Pharmaceutical Industries (TEVA) said Friday that the US Food and Drug Administration has approved WELTRUZA for extended-release injectable suspension of olanzapine for subcutaneous use as a treatment of schizophrenia in adults.

The company said WELTRUZA will be available in the US in the coming weeks in once-monthly subcutaneous injectable doses of 318 mg, 425 mg and 531 mg.

The injections will not require loading doses, oral supplementation, or post-injection monitoring, the company said.

Teva said approval was based on results from its phase-3 Solaris trial, which showed a significant reduction in illness severity and improvement in personal and social functioning.

The company said the treatment's safety profile was consistent with oral olanzapine, while reported adverse events included weight gain, sleepiness, headache, constipation and injection-site reactions.

Shares of the company were up 3.4% in Friday's premarket activity.

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