60A[degree sign] Pharmaceuticals announces submission of NDA to US FDA for antimalarial drug Tafenoquine.
M2 EQUITYBITES-December 19, 2017-60AaAaAeAe[degree sign] Pharmaceuticals announc submission of NDA to US FDA for antimalarial drug Tafenoquine
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60 Degrees Pharmaceuticals (60P), a provider of new medicines for treatment and prevention of tropical diseases, including malaria and dengue, said on Monday that it has successfully filed its New Drug Application (NDA) with the US Food and Drug Administration for the use of Tafenoquine in the prevention of malaria in adults travelling to areas where malaria is prevalent.
Malaria is a life-threatening disease caused by Plasmodium parasites that are transmitted to people through the bite of an infected mosquito. The disease poses a significant risk to healthy individuals travelling in many parts of the world, including employees of non-governmental organisations, casual vacationers as well as military forces.
In conjunction, the company had signed a cooperative research and development agreement with the US Army Medical Materiel Development Activity (USAMMDA) to develop Tafenoquine as a weekly prophylactic drug for the prevention of malaria.
This NDA submission is a culmination of over 30 years of research and development with the US Army Medical Research and Materiel Command, from the discovery of Tafenoquine at Walter Reed Army Institute of Research (WRAIR) through the current collaboration between the company and USAMMDA, added the company.
According to the company, Tafenoquine works against the major malaria parasites and all stages of the parasite's lifecycle and has been studied in more than 30 clinical trials involving more than 4,000 study participants.
A recent analysis of five clinical trials to assess the safety and tolerability of an investigational antimalarial agent, Tafenoquine, has been published in Travel Medicine and Infectious Disease, a peer-reviewed journal. The authors of the analysis conclude that the antimalarial agent Tafenoquine appeared to be safe and well tolerated when the anticipated clinical regimen (ACR) was administered, concluded the company.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Dec 19, 2017|
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