Submit active controlled CT design for moderate to very severe COPD patients: CDSCO Panel tells Zydus Healthcare on Revefenacin inhalation

New Delhi: Responding to Zydus Healthcare's proposal to manufacture and market Revefenacin Inhalation Solution 175 mcg/3ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit an active controlled clinical trial (CT) design considering the ethical issues with respect to the moderate to very severe chronic obstructive pulmonary disease (COPD) patients.

This came after Zydus Healthcare presented the proposal for grant of permission for manufacturing and marketing of the drug Revefenacin Inhalation Solution 175 mcg/3 ml with Phase III clinical trial protocol and bioequivalence (BE) study waiver before the committee.

Revefenacin is a novel biphenyl carbamate tertiary amine agent that belongs to the family of long-acting muscarinic antagonists (LAMA). The LAMA group falls into a parent category known as long-acting inhaled bronchodilators, and this type of agent is recommended as a maintenance therapy for chronic obstructive pulmonary disease (COPD). From the LAMA group, revefenacin is the first once-daily nebulized LAMA treatment.

Revefenacin is indicated as an inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

At the recent SEC meeting for Pulmonary, the expert panel reviewed the proposal presented by Zydus Healthcare for manufacturing and marketing of Revefenacin Inhalation Solution 175 mcg/3 ml with Phase III clinical trial protocol and bioequivalence (BE) study waiver

The committee deliberated in detail the need to follow GOLD 2024 guidelines and ensure categorization of COPD as per the latest guidelines. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guidelines categorize COPD into four stages based on airflow limitation.

Furthermore, the expert panel recommended the firm to submit an active controlled clinical trial design considering the ethical issues with respect to moderate to very severe COPD patients.

In addition, the firm is requested to submit the revised protocol for further evaluation by the committee.

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