Re: [新聞] 藥華藥獲美國 FDA核准一線用藥

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※ 引述《sandya ()》之銘言： : 原文標題：FDA Approves Treatment for Rare Blood Disease : 原文連結：https://www.prnewswire.com/news-releases/fda-approves-treatment-fo r- : rare-blood-disease-301423378.html : 發布時間：Nov 12, 2021, 16:55 ET : 原文內容：SILVER SPRING, Md., Nov. 12, 2021 /PRNewswire/ -- Today, the U.S. Fo : od and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) i nj : ection to treat adults with polycythemia vera, a blood disease that causes t he : overproduction of red blood cells. The excess cells thicken the blood, slow in : g blood flow and increasing the chance of blood clots. : "Over 7,000 rare diseases affect more than 30 million people in the United S ta : tes. Polycythemia vera affects approximately 6,200 Americans each year," sai d : Ann Farrell, M.D., director of the Division of Non-Malignant Hematology in t he : FDA's Center for Drug Evaluation and Research. "This action highlights the FD : A's commitment to helping make new treatments available to patients with rar e : diseases." : Besremi is the first FDA-approved medication for polycythemia vera that pati en : ts can take regardless of their treatment history, and the first interferon th : erapy specifically approved for polycythemia vera. : Treatment for polycythemia vera includes phlebotomies (a procedure that remo ve : s excess blood cells though a needle in a vein) as well as medicines to redu ce : the number of blood cells; Besremi is one of these medicines. Besremi is be li : eved to work by attaching to certain receptors in the body, setting off a ch ai : n reaction that makes the bone marrow reduce blood cell production. Besremi is : a long-acting drug that patients take by injection under the skin once ever y : two weeks. If Besremi can reduce excess blood cells and maintain normal leve ls : for at least one year, then dosing frequency may be reduced to once every f ou : r weeks. : The effectiveness and safety of Besremi were evaluated in a multicenter, sin gl : e-arm trial that lasted 7.5 years. In this trial, 51 adults with polycythemi a : vera received Besremi for an average of about five years. Besremi's effectiv en : ess was assessed by looking at how many patients achieved complete hematolog ic : al response, which meant that patients had a red blood cell volume of less t ha : n 45% without a recent phlebotomy, normal white cell counts and platelet cou nt : s, a normal spleen size, and no blood clots. Overall, 61% of patients had a co : mplete hematological response. : Besremi can cause liver enzyme elevations, low levels of white blood cells, lo : w levels of platelets, joint pain, fatigue, itching, upper airway infection, m : uscle pain and flu-like illness. Side effects may also include urinary tract i : nfection, depression and transient ischemic attacks (stroke-like attacks). : Interferon alfa products like Besremi may cause or worsen neuropsychiatric, au : toimmune, ischemic (not enough blood flow to a part of the body) and infecti ou : s diseases, which could lead to life-threatening or fatal complications. Pat ie : nts who must not take Besremi include those who are allergic to the drug, th os : e with a severe psychiatric disorder or a history of a severe psychiatric di so : rder, immunosuppressed transplant recipients, certain patients with autoimmu ne : disease or a history of autoimmune disease, and patients with liver disease . : People who could be pregnant should be tested for pregnancy before using Bes re : mi due to the risk of fetal harm. : Besremi received orphan drug designation for this indication. Orphan drug de si : gnation provides incentives to assist and encourage drug development for rar e : diseases. : The FDA granted the approval of Besremi to PharmaEssentia Corporation. : 心得/評論：台灣之光 : 市場之大後續看好 : 一線用藥股價才便宜的100 : 感謝全額交割股讓小股民有機會進場有人表示一線用藥跟放血阿斯匹靈一樣醫師不一定要使用但事實是，放血跟阿斯匹靈根本只能治標，不會治療PV ET疾病，許多病人後來只好吃HU （便宜），但是承受副作用。負擔得起的病人就用Pegasys （無FDA）or Jakafi （第二線）病友論壇之前很多人是使用Pegasys，但是在FDA唯一許可Besremi一線使用後，這個局勢應該會改變。加上原本使用Jakafi的二線病患，也有可能轉換過來（之後Besremi還有ET MPN的研究）營收樂觀不是空穴來風。至於歐洲為什麼賣不好，要問AOP 至少美國這部分FDA放一線指引一定是有影響力的。 -- ※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 223.136.165.90 (臺灣) ※ 文章網址: https://www.ptt.cc/bbs/Stock/M.1636948467.A.414.html

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