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2010年9月22日 星期三

諾華藥廠的Gilenya成為美國第一個通過FDA核准的MS口服藥物

諾華藥廠的MS口服藥 代號:Gilenya ( fingolimod / "FTY720")
已經獲得美國FDA的核准在美國上市了. 成為第一個通過核准的MS口服藥物.

- Gilenya is the first approved oral treatment indicated for relapsing forms of MS in the US, a major advance for people with this disease - Gilenya showed superior efficacy by reducing relapses by 52% at one year compared with interferon beta-1a IM, a commonly prescribed treatment - Two-year, placebo-controlled study showed that Gilenya significantly reduced the risk of disability progression - Well-studied safety and tolerability profile with over 2,600 clinical trial patients

WASHINGTON, D.C. (TheStreet) --U.S. regulators approved Novartis'(NVS) Gilenya, the first treatment for multiple sclerosis that patients take as a once-daily pill, the company announced Wednesday.
Gilenya's approval by the U.S. Food and Drug Administration instantly changes the competitive landscape for multiple sclerosis (MS) drugs. Existing MS drugs made by Biogen Idec(BIIB), Merck KGaA, Bayer and Teva Pharmaceuticals(TEVA) are all administered by injection.

Novartis is now the only company to offer an oral MS drug, which may spark instant demand from doctors and patients eager for the convenience of a pill. Studies have also demonstrated that Gilenya works better than some of its competitors at tamping down the symptoms of MS. One of the pivotal studies used to approve Gilenya showed the drug to be superior to Biogen's Avonex in preventing MS relapses.

Counteracting the excitement for the new MS pill, however, is a side effect profile that may make doctors hesitant to use Gilenya ahead of older, more established MS drugs.

Investors were widely expecting FDA to approve Gilenya, although the agency did so without a restrictive black box warning for safety concerns and a patient monitoring system less onerous than expected.

"Gilenya has been approved for multiple sclerosis in the U.S. with a prescribing label and a REMS [risk management] requirement that are probably the best possible outcome both Novartis and investors could have hoped for," wrote J.P. Morgan European pharmaceutical analyst Alexander Hauber in a Wednesday note to clients.

Analysts, on averge, forecasts more than $1 billion in peak sales for Gilenya.

Biotech investors are most interesting to see what impact Gilenya has on Biogen Idec, which markets Avonex, the best-selling MS drug used primarily in patients newly diagnosed with the disease; as well as Tysabri, considered the most effective MS drug but one that can also cause the serious brain infection progressive multifocal leukoencephalopathy (PML). As a result, doctors use Tysabri more as a second-line treatment in MS.

JP Morgan biotech analyst Geoff Meacham, in a recent note to clients, said his polling of MS doctors found that Gilenya would likely have minimal impact on front-line MS drugs such as Biogen's Avonex, Merck's Rebif, Bayer's Betaseron or Teva's Copaxone but could have a larger effect on Biogen's Tysabri (which is co-marketed by the Irish drug maker Elan(ELN).) He rates Biogen at neutral with a $55 price target.

Jefferies biotech analyst Thomas Wei is telling clients that Gilenya's approval and financial impact on Biogen's MS franchise is already largely baked into the stock's valuation. He rates Biogen a buy with a $66 price target.

中秋節快樂!!
台灣應該快進了吧...
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10 則留言:

  1. What happen right now with CCSVI in Taiwan? How many 'liberated'? How do they feel? Doctor Hu don't answer my emails anymore :/

    Is he on vacation?

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  2. Now as I know,there are at least 7 patients liberated. Not all of them have good response. Some have no progress before/after the procedure, and needing tracking still. One of the patients got another MS attack one week after the procedure(It has nothing to do with the treatment. That's really bad luck). Due to the results so far, and one major doctor(Dr.Tsai) in the team is abroad recently. The treatment will be delayed in this 2 months.

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  3. Thank you; I will try to be patient :|

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  4. 聯邦食品暨藥物管理局(FDA)22日宣布,它已批准治療最常見形式多發性硬化症(multiple sclerosis)的第一種口服藥上市,但提醒消費者此藥有副作用,包括新服用者可能心律增加、頭痛、患流感、腹瀉和背痛。

    FDA說,獲准上市的藥物是瑞士諾華藥廠(Novartis)製造的「Gilenya」。它說,此藥有助於阻止某些白血球進入腦部中樞神經系統中攻擊髓鞘(myelin),造成髓鞘損傷。髓鞘受傷將會造成神經訊號的傳導變慢,甚至停止。

    FDA表示,它批准Gilenya用於治療多發性硬化症病患,以減少病人失去平衡感、肌肉痙攣等症狀復發的次數。批准Gilenya上市被視為很有價值的進步,可以減少病人打針的麻煩,因為現有的治療法都需要注射藥物。

    多發性硬化症是一種免疫系統「無法分辨敵我」的疾病,無法根治。注射類固醇(steroid)短期可以縮短症狀的發作時間及減緩嚴重性,但市面上的七種現有治療法都需要每天注射或經常打針。

    美國大約有40萬人罹患多發性硬化症,全球患者則多達約250萬人。馬里蘭州患者摩根兩年前開始試服Gilenya。他說,現在他已免於症狀復發,他也沒有感受到副作用。摩根過去必須每隔一天為自己打針一次。

    華爾街分析師預測,Gilenya的銷售將達10億元。醫療數據業者指出,治療多發性硬化症藥物去年的總銷售量超過59億元。


    Read more: 世界新聞網-北美華文新聞、華商資訊 - 多發性硬化症口服藥 Gilenya上市

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  5. 昨天(9/27)由台大楊醫師那裡得到最新的訊息,口服藥已在美國上市沒錯,但台灣可能要到明年才會進,而並不是每位病友都可以使用,可能要看個人狀況吧!像我的狀況嚴重,他已告訴我口服藥對我可能是沒效的,有點失望,只好再尋找另外的治療方式了  娟

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  6. 你有問是怎樣判定你不適合此藥物的呢? 原因是?

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  7. 對呀!是怎樣判定自已適不適合口服藥呀~
    我不想經常性的施打干擾素呀~

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  8. 我所想到的就是問藥商囉,
    最快的方法就是---服用就知道是不適合了~
    副作用太強或太多 就可以考慮要不要再吃

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  9. Gilenya Costs $48,000 per Year
    Friday October 1, 2010


    I guess I'd call myself quietly disappointed and a little fatigued from this news. A Novartis AG company spokesperson has communicated to Bloomberg that their oral MS treatment, Gilenya (aka fingolimod), was going to be priced at $4,000 per month. (Read the Bloomberg article here: Novartis Gilenya MS Pill to Cost $48,000 a Year).

    Wow

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  10. 英文好消息就是特別靈通,羨慕…

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