Breaking News
February 21, 2018 - Early childhood immune signature predicts risk of developing asthma later on
February 21, 2018 - Stanford researchers explore how gut bacteria respond to common changes in habitat
February 21, 2018 - Household Products May Pollute the Air as Much as Your Car Does: Study
February 21, 2018 - Combo Bests Targeted Agent in mRCC
February 21, 2018 - Researchers discover brain pathway that dissociates opioid addiction from analgesia
February 21, 2018 - Scientists uncover how newly discovered gene helps grow blood vessels
February 21, 2018 - Brain’s quality control process holds clues to obesity’s roots
February 21, 2018 - Researchers to study whether menstrual cups can help prevent vaginal infections
February 21, 2018 - MS patients who feel stigmatized more likely to suffer from depression
February 21, 2018 - Vitamin D supplementation during pregnancy could protect against childhood obesity
February 21, 2018 - Lower-Quality Medical Tx Might Have Skewed Key PCI vs CABG Trials
February 21, 2018 - Love and fear are visible across the brain instead of being restricted to any brain region
February 21, 2018 - Adults with congenital heart disease have increased risk for dementia, study finds
February 21, 2018 - Clinical trial studying type 1 diabetes reaches full enrollment
February 21, 2018 - Father’s stress affects the brain development of offspring, mice study shows
February 21, 2018 - ESRD Death Declines in Vasculitis Patients
February 21, 2018 - Taking ibuprofen for long periods found to alter human testicular physiology
February 21, 2018 - Google AI device could predict a person’s risk of a heart attack
February 20, 2018 - FDA Approves Domestic Source for Tc-99m Isotopes
February 20, 2018 - Sanofi rejects refund demand faces Philippine suit over dengue vaccine (Update)
February 20, 2018 - Researchers discover that activation of specific enzyme may help suppress tumor metastasis
February 20, 2018 - Blood or marrow transplantation survivors have higher risk of cognitive impairment
February 20, 2018 - Booze Beats Pot at Being Unhealthy: Oregon Poll
February 20, 2018 - Morning Break: ’20 Years Late’; Drugs in the Dirt; Catching Flu in the Dorm
February 20, 2018 - Another piece to the puzzle in naked mole rats’ long, cancer-free life
February 20, 2018 - Scientists identify four viruses that can produce insulin-like hormones
February 20, 2018 - New e-Health solution developed to prevent cardiovascular disease, dementia in senior citizens
February 20, 2018 - New genetic risk score could help guide screening decisions for prostate cancer
February 20, 2018 - Study finds higher risk of stroke among blacks with atrial fibrillation than whites
February 20, 2018 - Physical activity could be used as strategy for diabetes prevention
February 20, 2018 - Researchers develop sensing method for early detection of cancer and diabetes
February 20, 2018 - New wearable electronics could be game-changer for stroke rehabilitation
February 20, 2018 - Immune history influences person’s response to flu vaccine
February 20, 2018 - Research findings could help develop new drugs to prevent, treat dry eye disease
February 20, 2018 - Serenity Now! Learn to Have Patience with Patients
February 20, 2018 - Computer simulation addresses the problem of blood clotting
February 20, 2018 - Women with type 1 diabetes not protected against coronary artery disease
February 20, 2018 - Persistent bloating can be a sign of ovarian cancer, warns charity
February 20, 2018 - Trump administration proposes rule to loosen curbs on short-term health plans
February 20, 2018 - Key protein involved in epigenetic regulation of gene expression guides skin cell renewal
February 20, 2018 - Heart attack symptoms often missed in women
February 20, 2018 - Diagnosis of celiac disease takes 3.5 years for patients who do not report GI symptoms
February 20, 2018 - Study reveals functional dynamics of ion channels
February 20, 2018 - Study explores link between mortality risk and combustible tobacco use
February 20, 2018 - ‘She Trusted Me, and I’d Turned Her Away’
February 20, 2018 - AbbVie and Voyager Therapeutics collaborate to develop new treatments for tauopathies
February 20, 2018 - Fast food makes the immune system more aggressive in the long term
February 20, 2018 - Therapeutic target for glaucoma could have treatment ramifications for Alzheimer’s and Parkinson’s
February 20, 2018 - Overcoming Negative Reviews | Medpage Today
February 20, 2018 - MyD88—villain of allergies and asthma
February 20, 2018 - Food scientists develop rapid screening technique to detect pesticide residue in vegetables
February 20, 2018 - Lab-grown cerebellar cells may help explain how ASD develops at molecular level
February 20, 2018 - Scientists explore connection between bad sleep habits and stiff blood vessels
February 20, 2018 - New Treatment Apalutamide (Erleada) Approved for Prostate Cancer That Resists Hormone Therapy
February 20, 2018 - Do You Really Need My Signature on That?
February 20, 2018 - HIV-1 genetic diversity is higher in vaginal tract than in blood during early infection
February 20, 2018 - Diabetes does not increase work-loss years due to early retirement
February 20, 2018 - Researchers aim to find out how PTSD affects decisions of police
February 20, 2018 - UH Cleveland Medical Center explores novel treatments for uterine fibroids
February 20, 2018 - Flu Vax Efficacy 25% Against Predominant H3N2 Strain So Far
February 20, 2018 - HIV screening most optimal at 25 years of age if no risk factors
February 20, 2018 - Loyola Medicine primary care physician offers advice to minimize risk of flu
February 20, 2018 - Safe sleep recommendations for parents that may help reduce child’s risk of SUID
February 20, 2018 - Why Do So Few Docs Have Buprenorphine Waivers?
February 20, 2018 - Low levels of alcohol good for the brain
February 20, 2018 - Experimental treatment improves invisible symptoms of a man with spinal cord injury
February 20, 2018 - Myriad’s EndoPredict offers better prediction of breast cancer recurrence, analysis shows
February 20, 2018 - Researchers identify fifteen genes that determine our facial features
February 20, 2018 - Morning Break: New Health IT Player; Luxturna No Bargain; Nuclear Freakout
February 20, 2018 - How does it compare? Hospice care at home, at assisted living facility, at nursing home
February 19, 2018 - Scientists develop water-soluble warped nanographene for bioimaging
February 19, 2018 - It’s Not Your Imagination: You’re Hungrier After Losing Weight
February 19, 2018 - Antihypertensive Use At Delivery Rising in Preeclampsia
February 19, 2018 - A centuries-old math equation used to solve a modern-day genetics challenge
February 19, 2018 - Liquid biopsies could be used as new predictive marker for metastatic TNBC
February 19, 2018 - Russian researchers develop new multi-layered biodegradable scaffolds
February 19, 2018 - Are ‘Vaccine Skeptics’ Responsible for Flu Deaths?
February 19, 2018 - Hidden genetic effects behind immune diseases may be missed, study suggests
February 19, 2018 - Emergency nurses experience regular verbal and physical abuse
February 19, 2018 - Study sheds light on biology that guides behavior across different stages of life
60° Pharmaceuticals (60P) Submits New Drug Application to US FDA for Antimalarial Drug Tafenoquine

60° Pharmaceuticals (60P) Submits New Drug Application to US FDA for Antimalarial Drug Tafenoquine

image_pdfDownload PDFimage_print

tafenoquine

Treatment for Malaria, Malaria Prophylaxis

60° Pharmaceuticals (60P) Submits New Drug Application to US FDA for Antimalarial Drug Tafenoquine

WASHINGTON, Dec. 18, 2017 /PRNewswire/ — 60 Degrees Pharmaceuticals (60P) announced it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration for the use of Tafenoquine to prevent malaria in adults traveling to areas where malaria is prevalent.

Malaria, a life-threatening disease caused by Plasmodium parasites that are transmitted to people through the bite of an infected mosquito, caused an estimated 429,000 fatalities and 212 million clinical cases in 2015.1 It poses a significant risk to millions of healthy individuals traveling in many parts of the world, including employees of non-governmental organizations (NGOs), casual vacationers, industrial and business workers, and military forces.2 Malaria cases among returning travelers in the U.S. have been trending upwards, with 84% of those infected requiring hospitalization.3

“There are real problems with the few anti-malarial drugs we currently have, including both resistance and safety issues. In particular, there can be a problem finding acceptable drugs to safeguard travelers and deployed military personnel,” said Dr. Stephen Toovey, Pegasus Research. “Tafenoquine should prove a useful alternative in combating malaria.”

“60P is proud of this significant milestone, a first for our organization,” stated Geoffrey Dow, Ph.D., CEO 60 Degrees Pharmaceuticals. “The work that has been done to date, including significant legacy research at the Walter Reed Army Institute of Research (WRAIR), establishes that Tafenoquine targets all types of malaria including the most common parasites (P. vivax and P. falciparum). We hope to market this product with a convenient weekly dosing regimen in the United States and eventually around the world,” Dr. Dow continued. “It is our belief our dossier will receive priority review, expediting the review of Tafenoquine, and 60P may qualify for a priority review voucher (PRV). This will help us acquire needed resources to provide this product to travelers who wish to be protected against deadly malaria parasites.”

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. As 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 NDA submission 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 Walter Reed Army Institute of Research (WRAIR) through the current collaboration between 60P and USAMMDA.

Researched for more than 30 years for both the prevention and treatment of malaria, Tafenoquine works against the major malaria parasites and all stages of the parasite’s lifecycle. Tafenoquine 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. In all five studies, the majority of adverse events (AEs) were mild or considered unrelated to the study drug. For the full article, “Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis,” by Moreno et al., 2017, please go to: http://www.travelmedicinejournal.com/article/S1477-8939(17)30079-0/fulltext

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 United States 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, a tropical disease, and monetized a PRV.

60P is headquartered in Washington DC, 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 United States Department of Defense or Department of the Army.

1 CDC. 2017. Malaria Facts. https://www.cdc.gov/malaria/about/facts.html

2 WWARN. 2017. Antimalarial Drug Resistance http://www.wwarn.org/about-us/malaria-drug-resistance

3 Cullen KA, Mace KE, Arguin PM. Malaria Surveillance-United States, 2013. MMWR Surveillance Summary 2016:65 (No.SS-2);1-22.

SOURCE 60 Degrees Pharmaceuticals, LLC

Posted: December 2017

Related Articles

tafenoquine FDA Approval History

Tagged with:

About author

Related Articles