A new drug as prophylaxis for malaria was approved three weeks ago-Arakoda. It is manufactured by 60 Degrees Pharmaceuticals, LLC. As a retired FDA Chemist and Team Leader, Anti-malarial Drugs was one of my expertise (for my GS-14 rating), so this approval still interests me, even though I have been retired since 2002(http://davidbkatague.blogspot.com/2011/12/fda-years-and-maryland-1990-2002.html).
Here's the announcement from www.pharmacytimes.com dated August 9, 2018.
"The US Food and Drug Administration (FDA) has approved tafenoquine (Arakoda) tablets manufactured by 60 Degrees Pharmaceuticals, LLC, for malaria prophylaxis in patients 18 years and older. This is the first new drug approved for the prevention of malaria in more than 18 years.
The approval comes on the heels of GlaxoSmithKline (GSK)’s tafenoquine (Krintafel) approval last month, which was the first single-dose medicine for the prevention of Plasmodium vivax malaria relapse in patients over the age of 16 years who are receiving antimalarial therapy. Krintafel is the first drug to be approved for the treatment of P vivax in over 60 years.
Both approvals were made under the contingency that GSK, and now 60 Degrees, complete post-marketing studies on the safety and efficacy of the drug formulations. Specifically, according to the FDA, GSK is required to "conduct an active pharmacovigilance study to evaluate safety, including hypersensitivity, neuropsychiatric, and hematologic adverse reactions, in patients taking Krintafel (tafenoquine) for the radical cure of P vivax malaria." Likewise, 60 Degrees is required to conduct "postmarketing studies to assess the drug's efficacy in children, older adults, and heavier individuals, and to answer questions about psychiatric safety and other adverse events."
Arakoda (tafenoquine) is an 8-aminoquinoline antimalarial drug indicated for the prophylaxis of malaria in patients aged 18 years and older.
Dosage and Administration
Loading regimen: (for each of the 3 days before travel to a malarious area)
200 mg (2 of the 100 mg tablets) once daily for 3 days
Maintenance regimen: (while in the malarious area)
200 mg (2 of the 100 mg tablets) once weekly – start 7 days after the last loading regimen dose
Terminal prophylaxis regimen: (in the week following exit from the malarious area)
200 mg (2 of the 100 mg tablets) one-time 7 days after the last maintenance dose
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.
For more information read the drug product insert.
For a list of other drug approvals for 2018 read the following site:
https://www.drugs.com/newdrugs.html
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