FDA批准阿茲海默症藥物每月維持劑量




美國FDA批准Eisai/Biogen的阿茲海默症藥物月度維持劑量

(路透社)— 美國食品藥品監督管理局(FDA)已批准日本Eisai及其合作夥伴Biogen(NASDAQ:BIIB)的阿茲海默症藥物Leqembi的月度維持劑量,這些公司在週一表示。

該藥物在2023年獲得標準美國批准,因其顯示能減緩患者的認知衰退,但增長緩慢,部分原因是其給藥過程繁瑣,需要定期進行MRI和篩查。

根據公司共同聲明,患者在接受了每兩周一次的靜脈注射18個月後,可以轉為每月一次的劑量。他們也可以選擇繼續每兩周一次的劑量。

Leqembi能清除大腦中一種名為淀粉樣蛋白β的粘性沉積物,這被認為是阿茲海默症的特徵。患者在注射中心接受藥物治療,過程幾乎需要一小時。

公司表示,試驗數據的模擬預測維持劑量將保持治療的益處。

Eli Lilly(NYSE:LLY)的一種競爭藥物Kisunla在七月獲得批准,並且是每月一次的注射。患者在腦部掃描不再顯示淀粉樣斑塊後停止治療。

這兩種藥物都有安全警告,指出可能出現腦部腫脹和出血的風險。建議患者進行掃描監測。

Eisai與BioArctic就該藥物簽訂了合作協議。

這次FDA的批准對於阿茲海默症的治療是一個重要的進展,因為它不僅提高了患者的治療選擇,還可能減少醫療資源的需求,尤其是在長期監控和多次訪問醫療設施的情況下。考慮到阿茲海默症患者及其家庭面臨的心理和經濟壓力,這種月度劑量的簡化可以顯著改善患者的生活質量。

然而,這兩種藥物的安全性問題仍然需要引起重視。患者在接受這些治療時必須定期進行監測,以避免潛在的副作用,這也可能影響到患者的依從性及治療效果。隨著這些新療法的推出,未來的研究應該集中於如何平衡治療效果與安全性,以便為患者提供最佳的治療方案。

以上文章由特價GPT API根據網上資料所翻譯及撰寫,過程中沒有任何人類參與 🙂

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A cinematic top-down portrait of a young woman standing on a solid deep green floor, captured from an extreme overhead angle. She looks up directly at the camera with wide, expressive eyes, creating an intimate and slightly surreal mood. She wears a soft white bucket hat, a cozy oversized green-and-beige checkered sweater, blue jeans, and white sneakers. Minimalist composition with vast negative space surrounding her, emphasizing isolation and calm. Soft diffused studio lighting, natural skin tones, subtle shadows, clean color grading with earthy greens, editorial fashion photography style, ultra-sharp focus, high resolution, modern aesthetic, cinematic framing, shot on a professional DSLR, shallow depth of field, Instagram poster vibe {
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"subject": {
"identity": "A stylish beautiful woman portrayed as Cleopatra during her sacred milk bath beauty ritual, embodying divine femininity, sensual elegance, and timeless power.",
"angle": "Close-up beauty editorial captured at a refined 3/4 angle, focusing on her face, shoulders, and upper chest with extreme clarity and no blur.",
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"body_position": "She is partially submerged in a luxurious milk bath, her shoulders and collarbones emerging gracefully from the surface.",
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"expression": "Soft yet commanding gaze directed toward the camera—calm, confident, intimate, and hypnotic."
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"appearance": {
"outfit": "A barely-there, ritual-style ivory silk drape partially submerged in the milk bath, clinging softly to her skin. The fabric is delicate and translucent, edged with fine gold-thread embroidery for a sensual, sacred aesthetic.",
"accessories": "Minimal ritual jewelry—thin gold collar necklace resting above the milk surface, delicate arm cuff, subtle finger ring—kept refined to maintain focus on beauty and skin.",
"hair": "Her hair is sleek and ritual-polished, partially damp and slicked back at the crown, with soft wet strands framing her face naturally, reflecting candlelight.",
"makeup": "High-fashion Cleopatra beauty makeup with ceremonial artistry—perfectly sculpted brows, elongated black kohl eyeliner, vibrant eyeshadow layered in turquoise, teal, emerald, sapphire blue, and metallic gold. Beneath the eyes, subtle artistic ink-inspired accents echo ancient Egyptian symbolism. Her skin is luminous and dewy, cheeks softly flushed, and lips finished in a nude-rose satin sheen."
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"ritual_props": {
"bath": "A carved alabaster bathtub filled with warm milk infused with honey, almond oil, and lotus essence.",
"floating_elements": [
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"beauty_products": [
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"lighting": {
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"camera_type": "DSLR",
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"shutter_speed": "1/160s",
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