AS, hainews.id – Badan Pengawas Obat dan Makanan Amerika Serikat (FDA) menyutujui obat Leqembi sebagai pengobatan bagi penderita tahap ringan dan awal Alzheimer pada Jumat (6/1/2023).
Persetujuan ini dikeluarkan tidak lama setelah badan pengawas itu dikritik keras karena telah memberikan izin penggunaan bagi jenis obat Alzheimer lainnya, yakni Aduhelm. Mereka dikritik karena telah mengeluarkan izin meskipun hasil uji coba produk menunjukkan bahwa pengobatan antibodi monoklonal berisiko menimbulkan pembengkakan dan pendarahan otak.
Kedua obat tersebut dikabarkan telah disetujui oleh FDA melalui proses yang dipercepat. Hal ini memungkinkan adanya kebutuhan yang tidak terpenuhi meski obat telah memperoleh izin.
Kendati demkikian, FDA menilai bahwa peluncuran Leqembi dan Aduhelm justru menjadi bukti kemajuan penting dari proses pengobatan yang bisa diterima oleh para penderita Alzheimer.
“[Kedua obat] mewakili kemajuan penting dalam perjuangan berkelanjutan untuk mengobati penyakit Alzheimer secara efektif”, terang FDA.
Perwakilan Pusat Evaluasi dan Penelitian Obat FDA Billy Dunn menyebut, tidak hanya untuk mengobata gejala Alzheimer, Leqembi juga akan menjadi jenis terapi terbaru yang berfungsi untuk menargetkan dan mempengaruhi proses penyakit yang mendasari Alzheimer.
Berdasarkan data uji coba Leqembi pada September 2022, obat ini disebutkan dapat memperlambat penurunan kognitif penderita Alzheimer hingga 27 persen.
Namun, menurut data uji coba lengkap yang diterbitkan dalam New England Journal of Medicine, pemberian obat bagi penderita Alzheimer mampu menimbulkan gejala efek samping termasuk pendarahan otak dan pembengkakan. Dari total 1.800 orang yang mengikuti uji coba fase ketiga, 17,3 persen di antaranya dipastikan mengalami pendarahan otak dan 12,6 persen lainnya mengalami pembengkakan otak.
Biaya Tinggi
Biogen dan Eisai ternyata sempat berupaya memasarkan produk Aduhelm ke pasaran. Namun, terjadi kontrovensi mengenai tingkat efektivitas Aduhelm dan persetujuannya pada 2021 telah menyebabkan pengunduran diri dari pejabat tinggi FDA.
Investigasi kongres AS menuturkan, proses persetujuan yang dipercepat untuk Aduhelm menunjukkan bahwa tahapan tersebut penuh dengan tidak kebeneran. Selain itu, Biogen juga mematok harga yang cukup tinggi untuk sebuah obat, yakni sekitar US$56.000 per tahun.
“Harga tinggi yang tidak dapat dibenarkan,” demikian tertulis dalam Laporan Kongres AS.
Senada dengan Aduhelm, produk Leqembi ternyata juga akan dipasarkan dengan harga yang cukup tinggi, yakni US$26.500 per tahun. Hingga 2026, sebanyak 100.000 orang Amerika diperkirakan telah menerima obat Alzheimer tersebut.
Meski demikian, biayanya yang sangat tinggi itu ternyata mendapat kritik dari sejumlah pihak, salah satunya adalah CEO Asosiasi Alzheimer Joanne Pike. Dia mengatakan bahwa harga yang sangat tinggi itu membuat kedua obat tersebut tidak dapat dijangkau oleh mayoritas masyarakat AS. Terutama jika biaya pengobatan mereka ditanggung oleh Mediacare, program asuransi kesehatan pemerintah untuk orang tua.
“Orang yang hidup dengan penyakit mematikan ini hari ini tidak punya waktu untuk menunggu obat atau penyembuhan ajaib,” ucap Pike.
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* La tasa de interés anual ofrecida para los depósitos en USD y Bitcoin es variable y puede cambiar en cualquier momento. Consulta nuestras Preguntas frecuentes sobre intereses para obtener más información. Los intereses de los depósitos en Bitcoin solo se pagarán sobre saldos de 5 BTC o menos. Para obtener más información, visita nuestro Centro de ayuda. Los intereses sobre el USD y el BTC se pagan actualmente en Satoshis. En su lugar, podemos optar por pagarlos en cualquier otra moneda o divisas admitidas (moneda fiduciaria o criptográfica) de vez en cuando. As for the economic implications, if history were a strict guide, we’d expect the price of Bitcoin to jump, as it has in the past after halvings. This represents a pivotal moment when the new supply of bitcoins entering the market is reduced, potentially driving up demand and prices if the market dynamics play out as they have in the past. However, do note that while history can offer insights, the cryptocurrency market’s volatility and susceptibility to various external factors make each halving a unique scenario.
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{Tôi đã khá hài lòng khám phá trang web tuyệt vời này. Tôi cần cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thưởng thức từng một chút nó và tôi cũng đã lưu làm mục ưa thích để xem điều mới trong trang web của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để khám phá một người mà thực sự hiểu họ là gì thảo luận trên internet. Bạn chắc chắn biết cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nên đọc điều này và hiểu khía cạnh này câu chuyện của bạn. Tôi đã ngạc nhiên rằng bạn không nổi tiếng hơn cho rằng bạn chắc chắn nhất có món quà.|Rất tốt bài viết trên blog. Tôi chắc chắn đánh giá cao trang web này. Cảm ơn!|Thật khó tìm những người có kinh nghiệm trong chủ đề cụ thể này, nhưng bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn cần tham gia một cuộc thi dành cho một trang web trên web tốt nhất. Tôi sẽ Rất khuyến nghị trang web này!|Một hấp dẫn chắc chắn đáng giá bình luận. Tôi tin rằng bạn nên xuất bản thêm về vấn đề này, nó có thể không là một điều cấm kỵ vấn đề nhưng thường xuyên mọi người không nói về những chủ đề như vậy. Đến phần tiếp theo! Cảm ơn rất nhiều.|Chào bạn! Tôi chỉ muốn đề nghị rất cho thông tin tuyệt vời bạn có ở đây trên bài đăng này. Tôi sẽ là quay lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ bất cứ khi nào có bình luận được thêm vào tôi nhận được bốn email cùng chính xác một bình luận. Có lẽ có một phương tiện bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn rất nhiều.|Lần sau Tôi đọc một blog, Tôi hy vọng rằng nó sẽ không làm tôi thất vọng nhiều như bài này. Ý tôi là, Tôi biết điều đó là sự lựa chọn của tôi để đọc hết, dù sao thì tôi thực sự nghĩ bạn sẽ có điều gì đó thú vị để nói. Tất cả những gì tôi nghe được là một loạt khóc lóc về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thực sự cảm thấy trang web này cần nhiều hơn nữa sự chú ý.
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{Tôi háo hức khám phá trang web này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thích thú từng của nó và tôi cũng đã đánh dấu để xem thông tin mới trong blog của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để khám phá một người mà thực sự hiểu họ là gì đang nói về trên web. Bạn thực sự nhận ra cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn thực sự cần xem điều này và hiểu khía cạnh này câu chuyện của bạn. Thật ngạc nhiên bạn không nổi tiếng hơn vì bạn chắc chắn có món quà.|Tốt bài viết trên blog. Tôi chắc chắn yêu thích trang web này. Cảm ơn!|Thật khó đến những người có kinh nghiệm cho điều này, nhưng bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn cần là một phần của một cuộc thi dành cho một blog trên internet hữu ích nhất. Tôi chắc chắn sẽ Rất khuyến nghị trang web này!|Một cuộc thảo luận thú vị chắc chắn đáng giá bình luận. Tôi nghĩ rằng bạn nên viết thêm về chủ đề này, nó có thể không là một điều cấm kỵ chủ đề nhưng thường xuyên mọi người không nói về vấn đề như vậy. Đến phần tiếp theo! Chúc mọi điều tốt đẹp nhất.|Xin chào! Tôi chỉ muốn đề nghị rất cho thông tin xuất sắc bạn có ở đây trên bài đăng này. Tôi sẽ là quay lại blog của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp vào hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ mỗi lần được thêm vào tôi nhận được bốn email cùng chính xác một bình luận. Phải có một cách bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn rất nhiều.|Lần sau Tôi đọc một blog, Hy vọng rằng nó sẽ không làm tôi thất vọng nhiều như bài này. Ý tôi là, Vâng, đó là sự lựa chọn của tôi để đọc hết, dù sao thì tôi thực sự nghĩ có lẽ có điều gì đó hữu ích để nói. Tất cả những gì tôi nghe được là một loạt tiếng rên rỉ về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thành thật tin trang web tuyệt vời này cần nhiều hơn nữa sự chú ý.
{Tôi hạnh phúc hơn cả vui khám phá trang web này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thích từng của nó và tôi cũng đã đã đánh dấu trang để xem điều mới trong trang web của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để khám phá một người mà thực sự biết họ là gì đang nói về trên internet. Bạn chắc chắn nhận ra cách đưa một rắc rối ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa phải kiểm tra điều này và hiểu khía cạnh này câu chuyện của bạn. Tôi đã ngạc nhiên bạn không nổi tiếng hơn vì bạn chắc chắn có món quà.|Rất tốt bài viết. Tôi chắc chắn đánh giá cao trang web này. Tiếp tục làm tốt!|Thật gần như không thể tìm thấy những người hiểu biết trong chủ đề cụ thể này, tuy nhiên, bạn có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn cần là một phần của một cuộc thi dành cho một trang web trên mạng tuyệt vời nhất. Tôi sẽ Rất khuyến nghị blog này!|Một cuộc thảo luận thú vị đáng giá bình luận. Tôi tin rằng bạn nên viết thêm về chủ đề này, nó có thể không là một điều cấm kỵ vấn đề nhưng nói chung mọi người không thảo luận chủ đề những điều này. Đến phần tiếp theo! Trân trọng!|Xin chào! Tôi chỉ muốn đề nghị rất to cho thông tin tuyệt vời bạn có ở đây trên bài đăng này. Tôi sẽ là trở lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ mỗi lần được thêm vào tôi nhận được bốn email có cùng nội dung. Có lẽ có một phương pháp dễ dàng bạn có thể xóa tôi khỏi dịch vụ đó không? Kudos.|Lần sau nữa Tôi đọc một blog, Hy vọng rằng nó không thất bại nhiều như bài này. Ý tôi là, Tôi biết điều đó là sự lựa chọn của tôi để đọc, tuy nhiên tôi thực sự tin có lẽ có điều gì đó thú vị để nói. Tất cả những gì tôi nghe được là một loạt khóc lóc về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thực sự nghĩ trang web này cần nhiều hơn nữa sự chú ý.
When I originally left a comment I seem to have clicked the -Notify me when new comments are added- checkbox and now whenever a comment is added I get four emails with the same comment. There has to be a means you are able to remove me from that service? Cheers.
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Bogs Holly Lace Leather: These boots are fashionable, snug, and absolutely waterproof, but they required a longer break-in interval than related pairs of waterproof footwear we examined.
The workers you interact to assist you in your business should likewise follow good personal hygiene.
They had been black people.
They aren’t solely extremely supportive and sturdy, but actually have all-day comfort.
As Darwin surveyed the vast variety of plant and animal life, a idea started to form in his thoughts: that the rich variation he encountered was due, not to divine creation, but to the technique of natural choice.
Plus, they are manufactured from Gore-Tex which, for environmental reasons, I’m on the fence about.
Alternatives for employment do exist for decrease-income households throughout cities, however it’s a problem to truly reach these neighborhoods-a spatial mismatch of sorts.
Thus, we provide a safe, comfortable environment the place people struggling with substance abuse can come and get non-judgmental therapy.
Whereas the economic affect could be immense, all this neglects to deal with the flagrantly unconstitutional use of unilateral motion in enacting such rules.
You’ll spend time attempting to convince individuals you’re the only sport in town as a substitute of significantly contemplating whether that’s true.
If you buy something that’s too wacky, then you definitely run a better threat of not liking the boots in the end.
DEF Corp. would make it seem that its earnings per share were growing quickly.
Noting the two points above both reduce the requirement for storage, and they do considerably, however it still exists so we nonetheless do need storage and which means both batteries and pumped hydro, not one or the other however each.
Stand out from the group with these trendy shoes and boots.
But I wonder whether or not within the slightly longer term his family truly came from simply over the border in Co.
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