The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Teva's long-acting formulation of schizophrenia drug risperidone, developed in partnership with MedinCell. This decision represents a significant setback for Teva, which has been striving to revitalize its business. The companies have not disclosed the specific reasons behind the FDA's rejection but have expressed their intention to collaborate with the agency to resolve the identified issues.
The injectable, subcutaneous formulation of risperidone, known as TV-46000/mdc-IRM, had shown promising results in phase 3 trials, with both one-month and two-month dosing regimens significantly delaying the risk of relapse compared to placebo. However, the FDA's decision has led to a 29% drop in MedinCell's shares on the Euronext Paris exchange.
TV-46000 utilizes MedinCell's BEPO technology, which involves combining the active drug with copolymers to form a depot that degrades over time, slowly releasing the medication. Despite the setback, MedinCell remains optimistic, citing the commonality of CRLs in the FDA regulatory process and the potential for approval following the resolution of deficiencies.
The market for long-acting injectables for schizophrenia is highly competitive, with products like Johnson & Johnson's Invega Hafyera, Invega Sustenna, and Invega Trinza, as well as Alkermes' Aristada, already established. The rejection of TV-46000 adds to the challenges Teva faces in its efforts to recover from previous business difficulties, including pricing pressures, the loss of patent protection for Copaxone, and debt from the acquisition of Actavis.
