Tafenoquine

The US Food and Drugs Administration Advisory Committee has endorsed tafenoquine, a single-dose drug from the GSK pipeline that targets one of the most frequent and widely distributed malaria parasites.

FDA’s Advisory Committee voted that there is substantial evidence of the effectiveness and adequate evidence of the safety of single-dose tafenoquine for the radical cure of Plasmodium vivax malaria in patients 16 years of age and older.

GSK’s submission included efficacy and safety data on tafenoquine from a comprehensive global clinical development program, designed in agreement with the FDA, comprising thirty-three studies in healthy volunteers and patients, of which more than 4000 trial subjects were exposed to the drug.

Thirteen of these studies directly support a radical cure program.

The primary evidence for the clinical efficacy and safety of the 300mg single-dose was provided by three randomised double-blind studies.

Pauline Williams, head of Global Health R&D, GSK said: “After extensive efforts to develop a new treatment for patients with P. vivax malaria, 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.”

Tafenoquine is not approved for use anywhere in the world. The new drug application (NDA) was submitted by GSK to the FDA in November 2017.

A regulatory submission was also made to the Australian Therapeutic Goods Administration (TGA) in December 2017 with a decision anticipated in the next few months.

Approvals of tafenoquine by the FDA and TGA would help support registrations in countries where P. vivax malaria is endemic and would be the first steps towards global adoption of the new medicine.