FDA: Krintafel approved as ‘radical cure’ for preventing malaria relapse

 

The Food and Drug Administration has approved, under priority review, single-dose tafenoquine (to be marketed as Krintafel) for the prevention of relapse in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute Plasmodium vivax infection, according to an announcement by research partners GSK and the nonprofit Medicines for Malaria Venture.

Courtesy NIAID

Tafenoquine is an 8-aminoquinoline derivative synthesized in 1978 at the Walter Reed Army Institute of Research. It is active against all stages of the P. vivax life cycle, including hypnozoites, and it was approved by an FDA priority review, according to the release.

Clinical efficacy and safety of the 300-mg single-dose tablet was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017.

Tafenoquine is referred to as a “radical cure,” because it targets the dormant liver forms of P. vivax and is coadministered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies.

“The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance,” David Reddy, MD, CEO of MMV stated.

The FDA approval letter and the Krintafel label information are available online.

mlesney@mdedge.com

 

The Food and Drug Administration has approved, under priority review, single-dose tafenoquine (to be marketed as Krintafel) for the prevention of relapse in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute Plasmodium vivax infection, according to an announcement by research partners GSK and the nonprofit Medicines for Malaria Venture.

Courtesy NIAID

Tafenoquine is an 8-aminoquinoline derivative synthesized in 1978 at the Walter Reed Army Institute of Research. It is active against all stages of the P. vivax life cycle, including hypnozoites, and it was approved by an FDA priority review, according to the release.

Clinical efficacy and safety of the 300-mg single-dose tablet was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017.

Tafenoquine is referred to as a “radical cure,” because it targets the dormant liver forms of P. vivax and is coadministered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies.

“The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance,” David Reddy, MD, CEO of MMV stated.

The FDA approval letter and the Krintafel label information are available online.

mlesney@mdedge.com

 

The Food and Drug Administration has approved, under priority review, single-dose tafenoquine (to be marketed as Krintafel) for the prevention of relapse in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute Plasmodium vivax infection, according to an announcement by research partners GSK and the nonprofit Medicines for Malaria Venture.

Courtesy NIAID

Tafenoquine is an 8-aminoquinoline derivative synthesized in 1978 at the Walter Reed Army Institute of Research. It is active against all stages of the P. vivax life cycle, including hypnozoites, and it was approved by an FDA priority review, according to the release.

Clinical efficacy and safety of the 300-mg single-dose tablet was provided by three randomized, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017.

Tafenoquine is referred to as a “radical cure,” because it targets the dormant liver forms of P. vivax and is coadministered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies.

“The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance,” David Reddy, MD, CEO of MMV stated.

The FDA approval letter and the Krintafel label information are available online.

mlesney@mdedge.com