FDA delays approval for Teva schizophrenia drug

Teva  credit: Shutterstock

Teva and its French partner MedinCell have received a Complete Response Letter, meaning that the New Drug Application cannot be approved in its present form.

The approval of Teva Pharmaceutical Industries' (NYSE and TASE: TEVA) original treatment for schizophrenia has been delayed. Teva's US unit Teva Pharmaceuticals and MedinCell (Euronext: MEDCL) reported yesterday that they had received a Complete Response Letter from the US Food and Drug Administration (FDA) to the New Drug Application they filed for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.

A letter of this kind is received when the FDA cannot approve an application in its existing form, and requests the company to carry out various actions in order to receive approval.

Teva says in its statement: "Teva and MedinCell remain committed to the development of risperidone and to providing patients with access to the product in the US as quickly as possible. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations."

Christophe Douat, CEO of Montpellier-based MedinCell, said, "We fully trust that our partner, Teva, will remedy this quickly given the positive results of the Phase 3 studies. Teva remains confident in MedinCell’s technology for the development of extended-release injectable products."

Teva had estimated that it would be able to obtain FDA approval to sell the drug in the US in the first half of this year. Data published by Teva in the past show the drug to be clinically effective and to start affecting patients within 24 hours of the first injection. The drug can be administered monthly or every two months. Teva believes that its new product is one of the most effective and convenient drugs for treating schizophrenia.

Teva has a market cap of $11.5 billion. Its share price is down 2.89% on the Tel Aviv Stock Exchange this morning.

Published by Globes, Israel business news - en.globes.co.il - on April 20, 2022.

© Copyright of Globes Publisher Itonut (1983) Ltd., 2022.

Teva  credit: Shutterstock
Teva credit: Shutterstock
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