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.
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