June 16, 2024

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FDA rejected Teva long-acting drug for schizophrenia

FDA rejected Teva long-acting drug for schizophrenia


FDA rejected Teva long-acting drug for schizophrenia

Recently, Teva and its partner MedinCell announced that the US FDA has issued a New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injection suspension, subcutaneous injection) for the treatment of adult patients with schizophrenia. A Complete Response Letter (CRL).


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Risperidone is a commonly used clinical drug for the treatment of schizophrenia, while TV-46000/mdc-IRM is a long-acting version of subcutaneous risperidone developed by MedinCell’s sustained-release delivery technology BEPO. Monthly or subcutaneously every 2 months.


The TV-46000/mdc-IRM NDA is based on data from 2 pivotal Phase 3 studies: TV46000-CNS-30072 (RISE study – subcutaneous extended-release study of risperidone) and TV46000-CNS-30078 (SHINE study – test TV-46000 Safety study of maintenance therapy in schizophrenia). The study evaluated the efficacy, long-term safety, and tolerability of TV-46000 (subcutaneously once monthly or every 2 months) for the treatment of patients with schizophrenia.


In the announcement, Teva did not disclose the specific issues identified by the FDA, but said it would work with the FDA to resolve them.


Analysts at investment bank Oddo BHF pointed out in a note that it is difficult to measure the impact of CRL without knowing more information. The date of market approval cannot be accurately predicted, but it is expected to be delayed by 9-12 months. Simple question review of manufacturing sites will only affect a 6-month delay, with an even bigger impact if additional clinical trials are required.


It is reported that Teva has been selling generic versions of Johnson & Johnson’s risperidone for more than 10 years. But since then, J&J has regained a foothold in the schizophrenia market by successfully developing long-acting versions of the drug.


In September last year, Johnson & Johnson’s Invega Hafyera (6-month paliperidone palmitate, PP6M) received FDA approval as the only drug for adults with schizophrenia that requires only two injections a year.

In the field of schizophrenia, Johnson & Johnson has launched products such as Risperdal Consta (risperidone), Invega Sustenna (1 month palisperidone palmitate), Invega Trinza (3 months palisperidone palmitate) . Combined sales of risperidone and long-acting products will reach $4.6 billion in 2021.


For Teva, the FDA accepted the marketing application for TV-46000/mdc-IRM after two Phase 3 clinical studies showed that the treatment was effective.

Investment bank Oddo BHF believes this shows that MediCell’s BEPO technology has not been questioned. In addition, some analysts are optimistic that if approved, TV-46000/mdc-IRM can still occupy a place in the market.






FDA rejects Teva, MedinCell’s schizophrenia drug

FDA rejected Teva long-acting drug for schizophrenia

(source:internet, reference only)

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