FDA Issues Complete Response Letter for Teva and MedinCell’s Long-Acting Subcutaneous Risperidone for Schizophrenia

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

Risperidone is a commonly used medication for the treatment of schizophrenia in clinical practice, while TV-46000/mdc-IRM is a long-acting subcutaneous injection form of risperidone developed using MedinCell's sustained-release delivery technology BEPO, administered once a month or every two months.

TV-46000/mdc-IRM NDA is based on data from two pivotal Phase 3 studies: TV46000-CNS-30072 (RISE Study - Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (SHINE Study - Evaluation of the Safety of TV-46000 in Maintaining Treatment for Schizophrenia). The studies assessed the efficacy, long-term safety, and tolerability of TV-46000 (administered subcutaneously once monthly or once every two months) for the treatment of patients with schizophrenia.

In the announcement, Teva did not disclose the specific issues pointed out by the FDA but stated that it would cooperate with the FDA to resolve these problems.

Oddo BHF Analysts Point Out in a Report: Without More Information, It's Hard to Gauge the Impact of CRL. The Timeline for Market Approval Cannot Be Accurately Predicted but Is Expected to Be Delayed by 9-12 Months. A Simple Issue with the Inspection of the Production Site Would Only Lead to a 6-Month Delay; However, If Additional Clinical Trials Are Required, the Impact Would Be Greater.

It is reported that Teva has been selling the generic version of Johnson & Johnson's Risperdal for more than 10 years. However, later on, Johnson & Johnson regained its foothold in the schizophrenia market by successfully developing a long-acting version of the drug.

In September last year, Johnson & Johnson's Invega Hafyera (6-month paliperidone palmitate, PP6M) received FDA approval in the United States. This medication is the only treatment for adult schizophrenia that requires only two injections per year. In the field of schizophrenia, Johnson & Johnson has also launched Risperdal Consta (risperidone), Invega Sustenna (1-month paliperidone palmitate), and Invega Trinza (3-month paliperidone palmitate). In 2021, the combined sales of risperidone and long-acting products reached $4.6 billion.

Teva: After two Phase III clinical trials demonstrated treatment efficacy, the FDA accepted the marketing application for TV-46000/mdc-IRM. Investment bank Oddo BHF believes this indicates that MedinCell's BEPO technology has not been questioned. Additionally, some analysts are optimistic that if approved, TV-46000/mdc-IRM could still secure a place in the market.

Reference Source: FDA Rejects Teva, MedinCell's Schizophrenia Drug