CDSCO Panel Rejects AbbVie's Clinical Trial Waiver Plea for Foslevodopa-Foscarbidopa Injection
New Delhi: Pharmaceutical major AbbVie Healthcare India Private Limited has failed to secure a complete clinical trial waiver from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for its fixed-dose combination (FDC) of Foslevodopa 240 mg + Foscarbidopa 12 mg per mL solution for injection.
After reviewing the company's proposal, the expert panel did not accept the request for a complete clinical trial waiver and instead recommended that the firm conduct a Phase III clinical trial in India before the application can proceed further.
Accordingly, the committee directed AbbVie Healthcare India Private Limited to submit the Phase III clinical trial protocol to CDSCO for further review by the committee.
At the recent SEC meeting, the company presented its proposal seeking a complete clinical trial waiver for the import and marketing of Foslevodopa 240 mg + Foscarbidopa 12 mg per mL solution for injection.
Foslevodopa/foscarbidopa represents a promising non-surgical alternative to the available device-aided therapies for patients with advanced Parkinson’s disease (PD) whose motor fluctuations are inadequately controlled by other oral PD medications.
Parkinson’s disease (PD) is a progressive movement disorder that causes the gradual loss of dopamine-producing neurons, leading to motor and non-motor symptoms.
During its presentation, the firm informed the committee that the fixed-dose combination has already been approved in several countries, including the United States, Japan and Canada.
However, the committee observed that the dosage form is intended to be administered using a medical infusion device that has not yet received approval from CDSCO. The firm informed the committee that it has already submitted an application seeking approval for the said device.
The expert panel also reviewed the global clinical data submitted by the company. However, it noted that no Indian patients participated in the global clinical trial, and the company did not present any safety and efficacy data generated in the Indian population.
In view of these observations, the committee concluded that the available evidence was insufficient to justify a complete waiver of local clinical trials.
After detailed deliberations, the Subject Expert Committee did not recommend the request for a clinical trial waiver and instead advised the company to conduct a Phase III clinical trial. The committee further recommended that the firm submit the Phase III clinical trial protocol to CDSCO for review before further consideration of the application.
