Teva wins FDA approval for monthly schizophrenia injection Weltruza

Oct 9 — Teva said on Friday it had received ​approval from the US Food and Drug Administration for Weltruza, a once-monthly injection ‌for adults with schizophrenia.

Weltruza is the second US-approved product ⁠from Israel-based Teva's ​partnership with French ⁠biotech company Medincell after Uzedy, a ‌long-acting injectable form ‌of antipsychotic drug risperidone, which the FDA ⁠approved in 2023.

• ⁠Teva, which leads the development and commercialisation of Weltruza, said it expected to launch the drug in the US in the coming weeks

• The product uses ‌Medincell's long-acting injectable technology, ​which is designed to release medicines over extended periods

• The long-acting formulation of antipsychotic medicine olanzapine may help address treatment-adherence challenges in schizophrenia and other chronic psychiatric illnesses

• Medincell may be eligible for up ​to $112 million in additional development and ‌commercial milestone ‌payments ⁠under its agreement with Teva, along with royalties on sales

• Shares of Teva were up 2% in Tel Aviv at 1124 ‌GMT; Medincell shares were suspended ​upon the company's request ‌ahead of the ⁠announcement

(Reporting ​by Lucie Barbier in Gdansk, editing by Milla ​Nissi-Prussak)

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