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60 Degrees Pharmaceuticals Announces Communication From the FDA of Intention to Respond to Tafenoquine-Babesiosis Trial Protocol Submission in April, 2024

60 Degrees Pharmaceuticals Announces Communication From the FDA of Intention to Respond to Tafenoquine-Babesiosis Trial Protocol Submission in April, 2024

60 Degrees Pharmicals 宣佈美國食品藥品管理局打算在 2024 年 4 月對他非諾喹-巴貝斯蟲病試驗方案提交做出回應
GlobeNewswire ·  03/14 19:59

WASHINGTON, March  14, 2024  (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc., (NASDAQ: SXTP, SXTPW) ("60 Degrees Pharmaceuticals" or the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company's babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company's existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame.

華盛頓,2024年3月14日(環球新聞專線)——專注於開發傳染病新藥的製藥公司60度製藥公司(納斯達克股票代碼:SXTP,SXTPW)(“60度製藥” 或 “公司”)今天宣佈,美國食品藥品監督管理局(FDA)已表示打算在2024年4月內就該公司的巴貝斯蟲病試驗發表任何評論,而不是公司預期的2024年3月。從技術上講,FDA指示的協議提交機制,即在公司現有(而不是新的)研究性新藥申請下,不需要FDA在規定的時間範圍內做出回應。

The Company is continuing preparations for a June 1, 2024 start date as previously communicated.

如先前所述,公司正在繼續爲2024年6月1日的開始日期做準備。

Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

他芬諾喹是美國食品藥品管理局於2018年批准的抗瘧藥物中的活性成分,適用於18歲及以上的患者的瘧疾預防。

About ARAKODA (tafenoquine)

關於 ARAKODA(他非諾昆)

Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA and in Australia as KODATEF. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.

塔芬諾喹是由沃爾特·裏德陸軍研究所發現的。他芬諾喹於2018年在美國以ARAKODA的名義獲准用於瘧疾預防,在澳大利亞以KODATEF的名義獲准用於瘧疾預防。兩者均於2019年商業上市,目前通過各自國家的藥品批發商網絡進行分銷。它們作爲處方藥預防瘧疾的藥物在零售藥房有售。

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less frequent dosing for prophylaxis for malaria. ARAKODA is not suitable for everyone, and patients and prescribers should review the Important Safety Information below.

根據美國疾病控制與預防中心的數據,他非諾喹較長的末期半衰期約爲16天,可能在降低瘧疾預防劑量的頻率方面具有潛在優勢。ARAKODA並不適合所有人,患者和處方者應查看以下重要安全信息。

ARAKODA (tafenoquine) Important Safety Information

ARAKODA(他芬諾昆)重要安全信息

ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

ARAKODA是一種抗瘧藥,適用於18歲及以上的患者預防瘧疾。

Contraindications

禁忌症

ARAKODA should not be administered to:

ARAKODA 不應用於:

  • Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status.

  • Lactating women who are breastfeeding 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.

  • Patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines or any component of ARAKODA.

  • 葡萄糖-6-磷酸脫氫酶 (G6PD) 缺乏症或 G6PD 狀態不明的患者。

  • 在發現嬰兒缺乏 G6PD 或 G6PD 狀況不明時正在進行母乳餵養的哺乳期婦女。

  • 有精神病史或當前精神病症狀的患者。

  • 已知對他芬諾昆、其他 8-氨基喹啉或 ARAKODA 任何成分有超敏反應的患者。

Warnings and Precautions

警告和注意事項

  • 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 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia and hypersensitivity reactions may be delayed in onset and/or duration.

  • 溶血性貧血:由於存在溶血性貧血的風險,在開ARAKODA處方之前必須進行G6PD測試。監測患者是否有溶血的體徵或症狀。

  • 妊娠期或哺乳期 G6PD 缺乏:ARAKODA 給胎兒缺乏 G6PD 的孕婦服用時,可能會對胎兒造成傷害。不建議在懷孕期間服用 ARAKODA。缺乏G6PD的嬰兒可能因通過母乳接觸ARAKODA而有發生溶血性貧血的風險。在開始母乳餵養之前,檢查嬰兒的 G6PD 狀態。

  • 高鐵血紅蛋白血癥:已觀察到血液高鐵血紅蛋白無症狀升高。如果出現高鐵血紅蛋白血癥的體徵或症狀,請開始適當的治療。

  • 精神影響:在有精神病或精神分裂症史的患者中,觀察到嚴重的精神病不良反應,其劑量與批准劑量不同。如果出現精神病症狀(幻覺、妄想或嚴重混亂的思維或行爲),請考慮儘快停止ARAKODA治療並由心理健康專業人員進行評估。

  • 超敏反應:服用ARAKODA時已觀察到嚴重的超敏反應。如果出現超敏反應,應採取適當的治療方法。

  • 延遲性不良反應:由於ARAKODA的半衰期較長(約16天),精神影響、溶血性貧血、高鐵血紅蛋白血癥和超敏反應的發作和/或持續時間可能會延遲。

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams and anxiety.

不良反應:最常見的不良反應(發生率大於或等於 1%)是:頭痛、頭暈、背痛、腹瀉、噁心、嘔吐、丙氨酸氨基轉移酶升高、暈車、失眠、抑鬱、夢境異常和焦慮。

Drug Interactions

藥物相互作用

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

避免與作爲有機陽離子轉運蛋白-2或多藥和毒素擠出轉運蛋白底物的藥物共同給藥。

Use in Specific Populations

在特定人群中使用

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.

哺乳:建議女性在治療期間和最後一劑ARAKODA後的3個月內不要母乳餵養缺乏G6PD的嬰兒或G6PD狀態不明的嬰兒。

譯文內容由第三人軟體翻譯。


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