CDSCO Panel Rejects AbbVie's Clinical Trial Waiver for Parkinson's Drug, Mandates Phase III Study in India
核心洞察
India's SEC refused AbbVie (搜索)'s request for a complete clinical trial waiver for its foslevodopa-foscarbidopa subcutaneous infusion for advanced Parkinson's disease (搜索).
The committee cited the absence of Indian patient data in global trials and the unapproved status of the accompanying infusion device as key reasons for the decision.
AbbVie (搜索) must now submit a Phase III clinical trial protocol to CDSCO (搜索) for review before the import and marketing application can proceed.
India's Subject Expert Committee (SEC) for Neurology and Psychiatry has rejected AbbVie (搜索) Healthcare India's plea for a complete clinical trial waiver on its foslevodopa-foscarbidopa fixed-dose combination (FDC) for advanced Parkinson's disease (搜索), instead directing the company to conduct a Phase III clinical trial in the Indian population.
The decision, taken during the SEC meeting on June 17, 2026 and released by the Central Drugs Standard Control Organisation (CDSCO (搜索)) on June 25, represents a significant regulatory hurdle for AbbVie (搜索)'s plans to bring the novel subcutaneous therapy to the Indian market.
Regulatory Concerns Drive Decision
The committee identified two primary concerns that precluded granting a clinical trial waiver. First, the FDC solution for infusion is designed to be administered via a medical infusion device that has not yet received CDSCO (搜索) approval. AbbVie (搜索) informed the committee that it has already submitted a separate application for the device's approval.
Second, and more critically, the SEC noted that while AbbVie (搜索) presented global clinical data supporting the drug's safety and efficacy, no Indian patients participated in the global clinical trials. The company did not present any safety and efficacy data generated specifically in the Indian population.
"After detailed deliberation, the committee did not consider CT waiver and recommended to conduct Phase III CT study," the SEC stated in its meeting minutes. "Accordingly, the firm should submit Phase III CT protocol to CDSCO (搜索) for further review by the committee."
A Novel Therapy for Advanced Parkinson's Disease (搜索)
Foslevodopa-foscarbidopa represents a promising non-surgical alternative to available device-aided therapies for patients with advanced Parkinson's disease (搜索) whose motor fluctuations are inadequately controlled by oral PD medications. Parkinson's disease is a progressive movement disorder characterized by the gradual loss of dopamine-producing neurons, leading to both motor and non-motor symptoms.
The FDC, comprising Foslevodopa 240 mg and Foscarbidopa 12 mg per mL solution for injection, is already approved in several major markets. The US Food and Drug Administration granted approval in October 2024, making it the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (搜索).
In the US, the drug is marketed under the brand name Vyalev, while in the UK and Europe it is sold as Produodopa. The therapy is administered using a portable infusion pump that delivers the medication below the skin continuously, seven days a week.
Global Clinical Evidence
The US FDA approval was supported by a Phase III, 12-week study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced Parkinson's disease (搜索) compared to oral immediate-release carbidopa/levodopa (CD/LD IR). A 52-week open-label study further evaluated the long-term safety and efficacy of the drug.
According to AbbVie (搜索), adults treated with Vyalev demonstrated superior improvement in "on" time without troublesome dyskinesia compared to those receiving oral immediate-release carbidopa or levodopa.
Path Forward
With the SEC's recommendation, AbbVie (搜索) Healthcare India must now design and submit a Phase III clinical trial protocol for review by the committee. The protocol will need to address the evidentiary gap regarding the drug's safety and efficacy profile in Indian patients before the import and marketing application can proceed further.
The decision underscores the CDSCO (搜索)'s increasing emphasis on generating local clinical data, even for therapies with established global regulatory approvals, reflecting a broader regulatory trend toward ensuring drug safety and efficacy across diverse populations.