Teva wins FDA approval for monthly schizophrenia injection Weltruza

(Corrects sourcing in bullet 3, updates share reaction in bullet point 5)

Oct 9 (Reuters) – 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

• Analysts see potential for long-acting antipsychotic formulations to help address treatment-adherence challenges in chronic psychiatric illnesses, as long-acting olanzapine may in schizophrenia

• 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 closed 2% higher in Tel Aviv; Medincell closed 16.9% higher in Paris

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