Breaking News
August 17, 2018 - Female mosquitoes quickly evolve selective mating behavior when faced with threats
August 17, 2018 - FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
August 17, 2018 - Resistance training and exercise motivation go hand-in-hand
August 17, 2018 - A lesson for future doctors: Listen to and learn from your patients
August 17, 2018 - NUS study discovers a bidirectional regulator and shines light on A-to-I RNA editing in cancer cells
August 17, 2018 - Research shows link between high blood levels of omega-3s and better brain function in children
August 17, 2018 - Researchers propose new theory for how rare gene mutations cause Alzheimer’s disease
August 17, 2018 - Digital psychiatric therapy can ‘rewire’ the brain in children with ADHD, study shows
August 17, 2018 - Psychologist to assess how the brain maintains precise short-term and long-term memories
August 17, 2018 - Eating white button mushrooms could improve regulation of glucose in the liver
August 17, 2018 - Scientists identify mutational signatures in ovarian cancer
August 17, 2018 - Sun Pharma receives U.S. FDA approval for CEQUA to treat patients with dry eye disease
August 17, 2018 - Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
August 17, 2018 - Study shows DNA methylation related to liver disease among obese patients
August 17, 2018 - Life on the border: Back at Stanford, ready to pitch in
August 17, 2018 - New device for accurately placing hemodialysis catheters on kidney patients
August 17, 2018 - New strategy accelerates, automates process of prototype molecule optimization
August 17, 2018 - Study finds role of autoimmunity in development of COPD
August 17, 2018 - Researchers transform research tool to study neuronal function
August 17, 2018 - Cognitive impairment does not equate to unhappiness in older adults
August 17, 2018 - Peer Comparisons Can Decrease Risky Prescribing Patterns
August 17, 2018 - Susceptible genes identified for childhood chronic kidney disease
August 17, 2018 - Research uncovers miscarriage cause, identifies potential targets for treatment
August 17, 2018 - Bacterial armor could be new target for antibiotics | News Center
August 17, 2018 - FDA expands approval of Vertex’ cystic fibrosis medicine to treat children aged 12 to
August 17, 2018 - Give Your Child a Head Start With Math
August 17, 2018 - Ground-breaking study tests whether rejected livers can be made viable for transplantation
August 16, 2018 - New algorithm could improve diagnosis of rare diseases | News Center
August 16, 2018 - SCHILLER introduces latest generation of ECG device, CARDIOVIT AT-102 G2
August 16, 2018 - Proper treatment, refraining from smoking can reduce heart disease risk from type 2 diabetes
August 16, 2018 - Mount Sinai study could transform treatment for patients with retinal degenerative diseases
August 16, 2018 - Penn researchers develop first mouse model of idiopathic pulmonary fibrosis
August 16, 2018 - Four tips to help prevent fall allergy symptoms
August 16, 2018 - Women’s Preventive Services Initiative says screen all women annually for urinary incontinence
August 16, 2018 - At Stanford, patient discovers the source of her headaches, nausea | News Center
August 16, 2018 - To Prevent Injuries in Young Baseball Players, Chris Ahmad Reaches Out to Parents
August 16, 2018 - Restoring blood flow may be linked to longer survival in patients with critical limb ischemia
August 16, 2018 - New model of genetically engineered immune cells may help fight solid tumors
August 16, 2018 - Maternal stress increases anxious and depressive-like behaviors in female offspring
August 16, 2018 - Childhood exposure to secondhand smoke increases risk of COPD death in adulthood
August 16, 2018 - Scientists uncover key control mechanism of DNA replication
August 16, 2018 - NIH begins first-in-human trial of experimental live, attenuated Zika virus vaccine
August 16, 2018 - Two diabetes medications don’t slow progression of type 2 diabetes in youth
August 16, 2018 - 5 Questions: How Stanford research is making MRI scans safer for kids | News Center
August 16, 2018 - Columbia Celebrates 25th Anniversary of White Coat Ceremony
August 16, 2018 - Phonak’s new smallest and most discreet Virto B-Titanium hearing aid
August 16, 2018 - New project aims to study growth of water-based microorganisms
August 16, 2018 - Immune cell found to play important role in photosensitivity
August 16, 2018 - Higher social dominance linked to faster decision-making in men
August 16, 2018 - Blood test in early pregnancy could determine a woman’s later risk for gestational diabetes
August 16, 2018 - New research confirms link between DDT exposure and autism
August 16, 2018 - Neurodevelopmental Anomalies, Birth Defects Linked to Zika ID’d
August 16, 2018 - Risk of heart failure up in ALVSD patients with diabetes
August 16, 2018 - Exercise reduces symptoms and fatigue in patients with chronic kidney disease
August 16, 2018 - Study reveals role of RUNX proteins in DNA repair
August 16, 2018 - New research finds no harm from average salt consumption
August 16, 2018 - Researchers develop new way of testing bacterial resistance to antibiotics
August 16, 2018 - Magnetic gene in aquarium fish could open doors to treatment for epilepsy, Parkinson’s
August 16, 2018 - Five tips for successful long-term breastfeeding
August 16, 2018 - Researchers identify brain networks involved in object naming
August 16, 2018 - Promoting HPV Vaccine Doesn’t Prompt Risky Sex by Teens: Study
August 16, 2018 - Treating Rheumatoid Arthritis: Search for a Cure
August 16, 2018 - Research shows in the long run, charcoal toothpaste likely won’t whiten teeth
August 16, 2018 - Seattle Children’s opens new clinic to provide convenient access to pediatric specialty care services
August 16, 2018 - Curious case of the lost contact lens
August 16, 2018 - GN Hearing unveils world’s first Premium-Plus hearing aid
August 16, 2018 - Parental life span linked with increased longevity and health in daughters
August 16, 2018 - Health leaders reveal ten most important medicines in NHS history
August 16, 2018 - Mobile health devices diagnose hidden heart condition in at-risk populations
August 16, 2018 - When it comes to shedding pounds, it pays to think big
August 16, 2018 - Liva Healthcare announces appointment of Thomas Cooke as clinical services manager in the UK
August 16, 2018 - New digital pharmacy aims to help people living with chronic care conditions
August 16, 2018 - Preventing ACL injuries in high school athletes
August 16, 2018 - Experts provide insight into novel concepts and approaches for stroke rehabilitation
August 16, 2018 - Scientists reverse congenital blindness in mouse model
August 16, 2018 - Study shows link between use of benzodiazepines and increased risk of Alzheimer’s disease
August 16, 2018 - Study provides new insight into how ‘trash bag of the cell’ traps and seals off waste
August 16, 2018 - Trial shows PARP inhibitor as novel treatment option for patients with advanced breast cancers
August 16, 2018 - Prenatal exposure to violence increases toddlers’ aggressive behavior to their mothers
August 16, 2018 - Can manipulating gut microbes improve cardiac function in patients with heart failure?
FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria

FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria

image_pdfDownload PDFimage_print

FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria

WASHINGTON, Aug. 9, 2018 /PRNewswire/ — 60 Degrees Pharmaceuticals (60P) announced today the U.S. Food and Drug Administration (FDA) approval of Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For the first time in more than eighteen years, the U.S. FDA approved a new drug for the prevention of malaria.

Millions of healthy individuals travel to areas where malaria is endemic, including those traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces. Arakoda has the potential to protect thousands of U.S. travelers from the devastating and life-threatening effects of malaria.

The marketing approval of Arakoda is the culmination of years of scientific discovery and research by experts in the field of Malariology and Infectious Disease. Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research (WRAIR). The approval was based on a concerted effort by the U.S. Army and 60P, involving over 21 clinical trials and over 3,100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.

“We have worked closely with the U.S. Army as their commercial partners to bring Arakoda to the U.S. market,” said Geoffrey Dow, Ph.D, CEO of 60P. “Arakoda provides effective protection against both of the major types of malaria (P. vivax and P. falciparum), killing the parasites in both the blood and liver.” Dow continued, “this provides the travel medicine community the option to prescribe an anti-malarial which provides protection in a large spectrum of malaria hot zones while utilizing what is considered by many physicians to be a more compliant dosing regimen. Arakoda is a significant addition to the armamentarium for the prevention of malaria.”

MAJ Victor Zottig, the product manager of tafenoquine for the U.S. Army Medical Materiel Development Activity stated “the FDA approval is a tremendous achievement for 60P and the U.S. military for their long, dedicated effort in the global protection of Service Members and civilian personnel against malaria.”

Arakoda is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, Arakoda is intended to be taken once a week which could offer convenience to the traveler.

The U.S. FDA Anti-Microbial Drugs Advisory Committee recently recommended the approval of Arakoda for the prevention of malaria based on its safety and efficacy profile. 60P has committed to the U.S. FDA to perform post-marketing safety surveillance studies to continue to gather data on this important tool against malaria.

Important Safety Information

Contraindications

Arakoda should not be administered to:

  • G6PD deficiency or unknown G6PD status
  • Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown
  • Patients with a history of psychotic disorders or current psychotic symptoms
  • Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of Arakoda

Warnings and Precautions

  • Hemolytic Anemia: G6PD testing must be performed before prescribing Arakoda due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
  • G6PD Deficiency in Pregnancy or Lactation: Arakoda may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. Arakoda is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to Arakoda through breast milk. Check infant’s G6PD status before breastfeeding begins.
  • Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
  • Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of Arakoda therapy and, evaluation by a mental health professional as soon as possible.
  • Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of Arakoda. If hypersensitivity reactions occur, institute appropriate therapy.
  • Delayed Adverse Reactions: Due to the long half-life of Arakoda (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions

The most common adverse reactions (incidence ≥1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of Arakoda.

To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

About Malaria

Malaria, a life-threatening disease transmitted through the bite of an infected mosquito, caused an estimated 429,000 fatalities and 212 million clinical cases in 2015, according to the CDC. Malaria cases among travelers returning to the U.S. have been trending upwards.1

About Arakoda

Tafenoquine is an 8-aminoquinoline chemically derived from Primaquine, with activity against all types of malaria. It was first synthesized by scientists at WRAIR in 1978.

60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) in 2014 to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. Since malaria is the top infectious disease threat to U.S. military Service Members overseas, the military maintains a robust anti-malarial drug development effort through internal research and commercial partnerships. The FDA approval is a culmination of over 30 years of research and development with the U.S. Army Medical Research and Materiel Command, from the discovery of tafenoquine at WRAIR through the current collaboration between 60P and USAMMDA.

About 60P

60P, founded in 2010, focuses on discovering, developing and distributing new medicines for treatment and prevention of tropical diseases, including malaria and dengue. 60P’s mission is supported through in-kind funding from the U.S. Department of Defense. The company also collaborates with prominent research organizations in the U.S., Australia and Singapore. In addition, 60P has been funded by Knight Therapeutics Inc. (TSX:GUD), a Canadian specialty pharmaceutical company that obtained FDA approval for Impavido, a product for leishmaniasis which is a tropical disease. 60P is headquartered in Washington D.C., with a subsidiary in Australia.

Further information is available on the company’s website, www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

The statements expressed herein are those of 60P and do not necessarily represent those of the U.S. Department of Defense or Department of the Army.

1 Cullen KA, Mace KE, Arguin PM. Malaria Surveillance-United States, 2013 MMWR Surveillance Summary 2016:65 (No.SS-2);1-22 DOI: http://dx.doi.org/10.15585/mmwr.SS6502a1

SOURCE 60 Degrees Pharmaceuticals

Posted: August 2018

Related Articles:

Arakoda (tafenoquine) FDA Approval History

Tagged with:

About author

Related Articles