GSK Gets CDSCO Panel Nod to Study antimalarial drug Tafenoquine

New Delhi: The pharmaceutical major GSK has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the antimicrobial drug Tafenoquine Tablets 50 mg /150 mg, used to prevent and to treat malaria.

However, this approval is subject to the condition that GSK should submit Independent data monitoring committee (IDMC) recommendations along with interim analysis reports of pediatric participants 12 to 18 years of age as per the protocol.

This came after the drug maker GSK presented the proposal along with the Phase III clinical trial protocol of Tafenoquine tablets 50mg/150 mg before the committee.

Tafenoquine belongs to a group of medicines, called antiprotozoals. It works by treating malaria, a red blood cell infection transmitted by the bite of a mosquito. It also prevents the development of the blood forms of the parasite, which are responsible for the relapse.

The mechanism of action of tafenoquine is not well established but studies have reported a longer and more effective action when compared to primaquine. The active moiety of tafenoquine, 5,6 ortho quinone tafenoquine, seems to be redox cycled by P. falciparum which is upregulated in gametocytes and liver stages. Once inside, the oxidated metabolite produces hydrogen peroxide and hydroxyl radicals. It is thought that these radicals lead to the parasite's death.

On the other hand, tafenoquine inhibits heme polymerase in the blood stage of parasites which explains the activity against the blood stages of parasites.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal along Phase III clinical trial protocol of Tafenoquine tablets 50mg/150 mg before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial as per the protocol presented, subject to the condition that the firm should submit IDMC recommendations along with an interim analysis report of pediatric participants 12 to 18 years of age as per the protocol to CDSCO for further review by the committee for extension of the study.

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