Re: [新聞] 藥華藥獲美國 FDA核准一線用藥

ichitakajoe 發表於 2021/11/15 上午11:54:25

看板Stock標題Re: [新聞] 藥華藥獲美國 FDA核准一線用藥作者

(joe)時間Nov 15 11:54:25 2021推噓 3 推:4 噓:1 →:15

※ 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-for-
: 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) inj
: ection to treat adults with polycythemia vera, a blood disease that causes the
: overproduction of red blood cells. The excess cells thicken the blood, slowin
: g blood flow and increasing the chance of blood clots.
: "Over 7,000 rare diseases affect more than 30 million people in the United Sta
: tes. Polycythemia vera affects approximately 6,200 Americans each year," said
: Ann Farrell, M.D., director of the Division of Non-Malignant Hematology in the
: FDA's Center for Drug Evaluation and Research. "This action highlights theFD
: A's commitment to helping make new treatments available to patients with rare
: diseases."
: Besremi is the first FDA-approved medication for polycythemia vera that patien
: ts can take regardless of their treatment history, and the first interferonth
: erapy specifically approved for polycythemia vera.
: Treatment for polycythemia vera includes phlebotomies (a procedure that remove
: s excess blood cells though a needle in a vein) as well as medicines to reduce
: the number of blood cells; Besremi is one of these medicines. Besremi is beli
: eved to work by attaching to certain receptors in the body, setting off a chai
: n reaction that makes the bone marrow reduce blood cell production. Besremiis
: a long-acting drug that patients take by injection under the skin once every
: two weeks. If Besremi can reduce excess blood cells and maintain normal levels
: for at least one year, then dosing frequency may be reduced to once every fou
: r weeks.
: The effectiveness and safety of Besremi were evaluated in a multicenter, singl
: e-arm trial that lasted 7.5 years. In this trial, 51 adults with polycythemia
: vera received Besremi for an average of about five years. Besremi's effectiven
: ess was assessed by looking at how many patients achieved complete hematologic
: al response, which meant that patients had a red blood cell volume of less tha
: n 45% without a recent phlebotomy, normal white cell counts and platelet count
: s, a normal spleen size, and no blood clots. Overall, 61% of patients had aco
: 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 infectiou
: s diseases, which could lead to life-threatening or fatal complications. Patie
: nts who must not take Besremi include those who are allergic to the drug, thos
: e with a severe psychiatric disorder or a history of a severe psychiatric diso
: rder, immunosuppressed transplant recipients, certain patients with autoimmune
: disease or a history of autoimmune disease, and patients with liver disease.
: People who could be pregnant should be tested for pregnancy before using Besre
: mi due to the risk of fetal harm.
: Besremi received orphan drug designation for this indication. Orphan drug desi
: gnation provides incentives to assist and encourage drug development for rare
: 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