【世界首款數位藥物獲批準!吞下去就把你的身體狀況告訴手機】
藥物還能數位化?現在,它們已經獲得美國 FDA(食品和藥物管理局)批准。
週二,日本大塚製藥(Otsuka Pharmaceutical Co)藥物與感應器搭配的做法,通過美國當局許可。大塚製藥把含有銅、鎂、矽等礦物質的微型晶片,添加至自家明星產品 Abilify 裡,主要應用在治療精神疾病等方面。
病患吞服這種藥品後,沙粒般大小的晶片將與體內胃液起反應,金屬元素間將有弱電壓產生,隨即病患皮膚上作感應用途的貼片將接收到來自人體內的訊號。然後訊號經由貼片,再傳至智慧手機應用。最終,晶片會在完成任務,比如說服用七天後,隨體內其他消化的食物,通過消化道排出。
對如醫生或病患監護者而言,這種數位藥物還是很有利好的。尤其患者可能存在不遵從醫囑、服藥時間& 間隔、服藥方法等不規範問題,降低藥物的有效性。此外,患者自身可能需服用多種藥物,時間表還各有差異,如果記性不好,確實是件麻煩事。而有數位藥物,能記錄相關數據,並透過手機提醒病患監護者,他們就能採取相應措施,避免患者因沒按時堅持服藥導致病情惡化等情況,和沒必要的花費產生。
說到數位藥片,矽谷有家醫療技術公司 Proteus 就做得這種生意。事實上,他們正是大塚製藥數位化藥片 Abilify 的技術提供方。Proteus 產品分為三部分,包括含有感應器的藥丸、貼片、App。由晶片手機人體內各生理指標,如心率、呼吸、身體角度、活動情況及睡眠模式,再將這些數據發送至病患的監護者,起到借助外力調控的作用。
2010 年,Proteus 的智慧貼片獲得 FDA 認證許可,兩年後智慧晶片藥丸也通過考驗。如今,花費數年時間測試藥物,大塚製藥數位化 Abilify 藥片同樣迎來春天。
在 Proteus 數位藥丸的實際案例—大塚製藥裡,前者的晶片與貼片配合精神疾病藥物使用。當然,就理論來說,任何藥物應該都能與 Proteus 的數位藥物提供方案相匹配。關鍵點在於監護者有持續知曉患者情況的必要,比如糖尿病等慢性病管理就能用得上。還有類似數位藥丸,HQ 公司用來監控身體溫度,對消防員、航天員等特殊從業者,保證溫度適宜也是種需求。
總的說來,就資本市場對 Proteus 的反應看,數位藥丸前景還是比較可觀。過去 10 年,Proteus 總共獲得超 3 億美元,投資名單上更是有許多諸如大塚製藥、瑞士製藥巨頭諾華等醫藥企業的身影。
但潛在的難題也有。比如患者數據的隱私考量,保險公司將知曉你身體內運作情況,成本與效益等,甚至一旦連藥物都數位化,黑客軟體攻擊即可輕易操縱人們的感知狀態,這是科技帶來的陰暗面。
可難否認的是,FDA 批准的世界首款數位藥物—大塚製藥 Abilify,已打開未來醫療科技的大門,今後應該會有越來越多的數位藥物出現。無論是助益現在難解決的慢性病,還是用作其他特殊用,數位藥物都是值得探索的未來。
新聞來源:INSIDE
畫面來源:RTV
otsuka藥物 在 台灣光鹽生物科技學苑 Facebook 的最佳貼文
<生醫新聞>Cyclacel臨床三期的急性骨髓性白血病藥物在關鍵研究中失敗
#AcuteMyeloidLeukemia #FailedTrials #ClinicalResearch #Cyclacel #Decitabine #Sapacitabine #FDA
Cyclacel Pharmaceuticals has been taught the meaning of futility. Two years after an independent data monitoring board told Cyclacel its phase 3 acute myeloid leukemia (AML) trial was destined to fail, the ever-optimistic biotech has reported its drug sapacitabine was unable to better the active control in terms of overall survival.
The top-line data confirm an outcome that looked likely from the minute independent advisers told Cyclacel the study had failed an interim futility review in December 2014. By then, the phase 3 trial had chalked up 247 of the 424 patient deaths needed to trigger the end of the study. But, with the review finding no safety issues that would force Cyclacel to shutter the study, the NJ-based biotech pushed ahead regardless.
A little more than two years later, Cyclacel has learnt sapacitabine is no better at improving overall survival in elderly patients with AML than decitabine, an Otsuka drug FDA rejected in the indication in 2012 on the basis that it also failed to outperform the control arm in its own study. Decitabine, sold under the name Dacogen as a treatment for myelodysplastic syndromes, is used off-label in elderly AML patients because of the dearth of options in this population.
When combined with the performance of sapacitabine against some secondary endpoints, the lack of options for elderly patients with AML who cannot or will not undergo chemotherapy has given Cyclacel encouragement to continue seeking a way forward for the drug.
“We plan to discuss the data with European and U.S. regulatory authorities once subgroup analyses are completed over the next few months and will report our further plans as they develop,” CEO Spiro Rombotis said in a statement.
Rombotis and the chair of the phase 3, MD Anderson’s Hagop Kantarjian M.D., picked out the data on complete remission and safety as cause for optimism. Kantarjian, a critic of FDA’s decision to reject decitabine in AML, called the improved rate of complete remission “remarkable.” Cyclacel said the safety of the two arms was similar.
While Rombotis and Kantarjian see the data as suggesting it is still too early to write off sapacitabine, investors were less optimistic. Cyclacel dropped 30% in premarket trading, adding further woes to a stock that is down 99% on the highs it hit a decade ago. The company’s market cap prior to news of the latest setback stood at $24 million.
資料來源:http://www.fiercebiotech.com/…/cyclacel-aml-drug-fails-phas…
otsuka藥物 在 2021年6月12日藥物治療(抗病毒藥物、免疫抑制劑 - YouTube 的推薦與評價
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