Published On: Wed, Jul 18th, 2018

FDA panel adopts positive opinion over GSK malaria drug tafenoquine

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An advisory committee of the United States Food and Drug Administration (FDA) has endorsed GSK tafenoquine to be used as a single-dose for the treatment and relapse prevention of Plasmodium vivax (P. vivax) malaria in patients, aged 16 years and more.

The Antimicrobial Drugs Advisory Committee (AMDAC) of the FDA had voted unanimously in support of the GSK malaria drug for the radical cure of the malarial infection caused by Plasmodium vivax, which is a protozoal parasite and also a human pathogen.

Commenting on AMDAC’s favorable voting for the GSK malaria drug, Pauline – Head of Global R&D, GSK, said: “After extensive efforts to develop a new treatment for patients with , working in collaboration with Medicines for Malaria Venture, we welcome this endorsement.

“If approved, tafenoquine would be the first new medicine for this indication in more than 60 years. Together with our partners, we look forward to the final decision by the FDA.”

GSK Malaria Drug tafenoquine Developed in Collaboration with Medicines for Malaria Venture

GSK malaria drug tafenoquine is being developed in collaboration with Medicines for Malaria Venture.

Image: GSK malaria drug tafenoquine is being developed in collaboration with Medicines for Malaria Venture (MMV). Photo courtesy of Damien Schumann/MMV 2018.

An 8-aminoquinoline derivative, tafenoquine has been developed by GSK in collaboration with Medicines for Malaria Venture (MMV). Tafenoquine is said to have activity against all stages of the lifecycle of P. vivax, including hypnozoites.

All the 13 members of the AMDAC panel voted that there is considerable evidence of the effectiveness of tafenoquine while 12 members voted that there is enough evidence of the safety of the GSK malaria therapy.

David Reddy – CEO of Medicines for Malaria Venture, commenting on AMDAC’s endorsement of the GSK malaria drug tafenoquine, said: “Our 12-year collaboration with GSK on this project has resulted in the development of a medicine with the potential to improve the management of P. vivax malaria, offering a single-dose radical cure.

“The positive vote is an important step towards tafenoquine becoming a significant addition to the global anti-malaria arsenal.”

The AMDAC’s favorable voting will not be binding on the FDA to take a call on the GSK malaria drug, however, it is expected to be a key factor.

GSK malaria drug tafenoquine is proposed to be branded as Krintafel in the US should it secure an FDA approval.

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