2021年最關注的4款新藥：阿茲海默症、乾癬

《最值得關注的藥物預測》（Drugs to Watch）年度報告，在2021年已核准或即將核准的新藥和生物製劑中列出了4種可能暢銷的藥物，分別來自慢性、持續進展以及使人衰弱的疾病治療藥物：

阿茲海默症治療藥物--Aducanumab
全球約有5千萬名阿茲海默症患者，阿茲海默症患者通常在 65 歲以後才被診斷出來，但在出現症狀之前，病患的大腦往往退化已經數年、甚至數十年。

阿茲海默症患者的病徵是大腦出現病變，如「β澱粉類蛋白」異常聚集，這種現象多在患者出現阿茲海默症的明顯症狀前20年開始出現。由美國藥廠Biogen和Eisai共同開發的Aducanumab，主要是針對這些致病的機轉來進行標靶藥物開發，目標能緩解退化現象。

而Aducanumab被視為是最有機會不能通過的藥品，雖然在2020年7月向美國食藥局（FDA）申請上市，但之後卻被FDA認為證據不足。

最新進展是，Biogen和Eisai於今年1月底宣布，已接獲FDA延長生物製劑許可證申請（BLA）的通知，將盡力提供更多分析與臨床數據。

乾癬治療藥物--bimekizumab
乾癬的全球患病率約為2%-3%，並且可能引發身上其他的自體免疫疾病。由UCB研發的bimekizumab雖然上市時間較晚，但其療效優於目前的用藥，且嚴重副作用較少，因此預期該藥具有最佳療效。

前列腺癌口服藥--Relugolix
前列腺癌是全球男性的第二大常見惡性腫瘤，由武田研發的Relugolix是口服製劑首創（first-in-class）新藥，比起注射用的藥品相比，口服製劑更具優勢。同時，Relugolix也可用於治療困擾數百萬女性的子宮內膜異位症和子宮肌瘤，被看好能增加該藥品成功上市且大量使用的機率。

心衰竭治療藥物--Vericiguat
拜耳和默克聯合研發的Vericiguat是一種治療心衰竭的創新藥物，也是首款專門針對射血分數降低的慢性心衰竭（HFrEF）高危險族群的治療藥物。

這項報告在2021年達到臨床二期或以上階段的的藥物，製作出年度潛力暢銷藥物列表，並通過查詢年度報告、藥物產品線、臨床試驗、專利、化學資訊、交易、監管狀況等，對每種藥物進行了研究和評估。

​Among new drugs and biologics that have either won approval or are on the cusp of doing so, Clarivate has identified four treatments that are likely to achieve blockbuster status, delivering annual sales of more than $1 billion, within five years. The 2021 Drugs to Watch include: ​

• Aducanumab, developed by Biogen and Eisai– a potential game changer in the fight to build a pharmacopeia against Alzheimer’s disease, which affects an estimated 50 million patients worldwide. If approved, aducanumab would be the first disease-modifying therapy for Alzheimer’s disease and could unlock a monumental opportunity to radically change patient care and transform the market. If approved, demand for treatment will be enormous, potentially even decreasing willingness to forgo this treatment for an investigational drug in future clinical trials.
• Bimekizumab, developed by UCB– which offers significantly fewer side effects to patients with psoriasis, a condition affecting an estimated 2-3% of the global population, and a host of other autoimmune diseases. While bimekizumab is a late-class entrant providing incremental improvement over existing treatment options, it is expected to have best-in-class efficacy and fewer serious side effects.
• Relugolix, developed by Takeda– one of the first of a new class of treatments, with an oral formulation to address prostate cancer, the second-most-common malignancy afflicting men, as well as endometriosis and uterine fibroids, painful conditions affecting millions of women. Its potential use for three indications increases its chances of success. The oral formulation provides advantages over the injectable GnRH agonist competitors, including convenience and better management of side effects.
• Vericiguat, developed by Bayer and Merck– an innovative heart failure treatment and the first indicated specifically for high-risk, chronic heart failure with reduced ejection fraction (HFrEF), a particularly at-risk population. Vericiguat’s novel mechanism of action should result in its acceptance as an add-on therapy to existing treatments. It will likely find its niche among high-risk HFrEF patients, become a welcome addition to the treatment armamentarium and expand their treatment options.​

關鍵字：Aducanumab、阿滋海默症、Relugolix、前列腺癌、bimekizumab、乾癬、Vericiguat、心衰竭、CHF、Alzheimer、psoriasis​

資料來源：Clarivate Drugs to Watch Report Highlights Four Likely Blockbusters Among Drugs Launching in 2021

https://clarivate.com/cortellis/news/clarivate-drugs-to-watch-report-highlights-four-likely-blockbusters-among-drugs-launching-in-2021/


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