Nem kapott engedélyt az Alzheimer-gyógyszer
Pöltz Ágnes
2021.12.19. 16:05
Az Európai Gyógyszerügynökség (EMA) humángyógyszerészeti bizottságának (CHMP) decemberi ülésén elutasítást nyert az aducanumab (Aduhelm, Biogen) ellentmondásos Alzheimer-gyógyszerének forgalmazási kérelme.
A CHMP egy novemberi meetingjén már az engedély megtagadása ellen szavazott, így a végső döntés nem jelentett meglepetést.
A bizottság megjegyzése szerint ugyan az aducanumab valóban csökkenti az amyloid béta jelenlétét az agyban, mindez a klinikai javulással nem mutat egyelőre megalapozott kapcsolatot.
A szakértők továbbá úgy érezték, hogy a gyógyszervizsgálatok eredményei ellentmondásosak és nem szolgáltatnak perdöntő bizonyítékot arra vonatkozóan, hogy a szer hatékony lenne a korai Alzheimer-kór kezelésében.
A bizottság hozzátette, hogy a biztonságosság kitétele is megkérdőjelezhető, mivel egyes betegek agyi képalkotó vizsgálatain olyan abnormális jeleket találtak, amik az agy duzzanatára vagy vérzésre utalhattak, és amik potenciálisan károsak lehetnek. Kiemelték, hogy a klinikai gyakorlatban ezeket az abnormalitásokat nem monitorozzák.
Mindezek nyomán a bizottság arra a következtetésre jutott, hogy az aducanumab előnyei nincsenek túlsúlyban a kockázatokkal szemben és ennek nyomán nem javasolhatják piaci forgalmazásra a szert.
A szer gyártója, a Biogen a negatív vélemény kézhez kapását követő tizenöt napon belül felülvizsgálatot kérelmezhet.
Idén júniusban Amerikában az Élelmiszer- és Gyógyszerbiztonsági Hivatal (FDA) jóváhagyta az amyloid-ellenes gyógyszer használatát a korai Alzheimer-kór kezelésében – annak ellenére, hogy a szakértői bizottságuk itt is az engedély ellenében érvelt.
Több hétnyi hangos vita és felháborodást követően egy hónappal később az FDA megbízott vezetője, Dr. Janet Woodcock amerikai szövetségi nyomozást kérvényezett a saját intézményük engedélyezési gyakorlatának kivizsgálására.
Iratkozzon fel hírlevelünkre!
Harmadik fél részére nem adjuk ki az e-mail címét!
NYOMKÖVETÉS (string) «https://work1.felejtek.hu»
(string) «{modul:wd_article}»
INCLUDE MODUL: felejtek_meta CALL: Andrea\Plugins\Felejtek\Felejtek::modul_felejtek_meta (0,0021 mp)
INCLUDE MODUL: jsonld CALL: Andrea\Plugins\JsonLD\JsonLD::modul_json_ld (0,0000 mp)
INCLUDE MODUL: owm_daily_mobile MISSED CALL (owm_daily_mobile).
INCLUDE MODUL: felejtek_menu:1 CALL: Andrea\Plugins\Felejtek\Felejtek::modul_felejtek_menu (0,0367 mp)
INCLUDE MODUL: wd_article CALL: Andrea\Plugins\Webdoki\MagazineArticle::modul_wd_article (0,0019 mp)
INCLUDE MODUL: felejtek_box:250 CALL: Andrea\Plugins\Felejtek\Felejtek::modul_felejtek_box (0,0003 mp)
INCLUDE MODUL: felejtek_box:248 CALL: Andrea\Plugins\Felejtek\Felejtek::modul_felejtek_box (0,0003 mp)
INCLUDE MODUL: basemenu CALL: Andrea\Core\PageList::modul_basemenu (0,0002 mp)
INCLUDE MODUL: comments MISSED CALL (comments).
INCLUDE MODUL: felejtek_related_articles CALL: Andrea\Plugins\Felejtek\Felejtek::modul_felejtek_related_articles (0,0000 mp)
INCLUDE MODUL: felejtek_suggested_articles CALL: Andrea\Plugins\Felejtek\Felejtek::modul_felejtek_suggested_articles (0,0025 mp)
MUNKAMENET VÁLTOZÓ array (
'SID' => 'b5758cf7c2c5ea065a9214c9e49f5412',
'user' => 'O:16:"Andrea\Core\User":5:{s:8:"login_ok";b:0;s:13:"inner_modules";a:0:{}s:8:"template";s:0:"";s:5:"items";N;s:8:"' . "{debug_info}" . '*' . "{debug_info}" . 'props";a:4:{s:7:"message";s:0:"";s:10:"user_group";O:21:"Andrea\Core\UserGroup":4:{s:13:"inner_modules";a:0:{}s:8:"template";N;s:5:"items";N;s:8:"' . "{debug_info}" . '*' . "{debug_info}" . 'props";a:0:{}}s:15:"registered_date";s:0:"";s:8:"topic_id";a:0:{}}}',
'lang' => 'hu',
'currency' => 'huf',
'a' => 'cikk',
'p' => '1',
'article' => 744,
'template_path' => '/templates/felejtek2023',
)KIKÜLDÖTT SQL KÉRÉSEK PDO connected to localhost.
SET SESSION `character_set_client` = 'utf8' (0 sor: 0.0002 mp/0.0002 mp)
SET SESSION `character_set_connection` = 'utf8' (0 sor: 0.0000 mp/0.0002 mp)
SET SESSION `character_set_database` = 'utf8' (0 sor: 0.0000 mp/0.0002 mp)
SET SESSION `character_set_filesystem` = 'utf8' (0 sor: 0.0000 mp/0.0003 mp)
SET SESSION `character_set_results` = 'utf8' (0 sor: 0.0000 mp/0.0003 mp)
SET SESSION `character_set_server` = 'utf8' (0 sor: 0.0000 mp/0.0004 mp)
SET SESSION `collation_connection` = 'utf8_hungarian_ci' (0 sor: 0.0001 mp/0.0004 mp)
SET SESSION `collation_database` = 'utf8_hungarian_ci' (0 sor: 0.0000 mp/0.0005 mp)
SET SESSION `collation_server` = 'utf8_hungarian_ci' (0 sor: 0.0000 mp/0.0005 mp)
SET SESSION `group_concat_max_len` = 1024 (0 sor: 0.0000 mp/0.0005 mp)
SELECT * FROM `alz_core_plugin`
WHERE `domain_id` = ? AND `option_active`=1
ORDER BY `depend_nums` ASC (9 sor: 0.0007 mp/0.0012 mp)
SELECT `name`,`value` FROM `alz_core_param` WHERE domain_id = ? (18 sor: 0.0005 mp/0.0017 mp)
SELECT * FROM `alz_mag_topic_right` WHERE `user_id`= (0 sor: 0.0001 mp/0.0018 mp)
SELECT * FROM `alz_mag_topic_right` WHERE `user_id`= (0 sor: 0.0001 mp/0.0019 mp)
SELECT * FROM `alz_mag_topic_right` WHERE `user_id`= (0 sor: 0.0001 mp/0.0019 mp)
SELECT * FROM `alz_mag_topic_right` WHERE `user_id`= (0 sor: 0.0001 mp/0.0020 mp)
SELECT * FROM `alz_mag_topic_right` WHERE `user_id`= (0 sor: 0.0000 mp/0.0021 mp)
SELECT * FROM `alz_mag_topic_right` WHERE `user_id`= (0 sor: 0.0000 mp/0.0021 mp)
SELECT `name`,`value` FROM `alz_core_lang` WHERE domain_id = ? (34 sor: 0.0002 mp/0.0023 mp)
SELECT id FROM alz_core_page WHERE domain_id = ? AND permalink = ? (0 sor: 0,0003 mp/0,0026 mp)
SELECT `theme_id` FROM `alz_core_domain` WHERE `id`=1 (1 sor: 0,0002 mp/0,0029 mp)
SELECT * FROM `alz_core_theme` WHERE (`id`=2) LIMIT 1 (1 sor: 0,0002 mp/0,0031 mp)
SELECT * FROM `alz_mag_topic` ORDER BY option_status DESC,`id` ASC (4 sor: 0,0003 mp/0,0033 mp)
SELECT * FROM `alz_mag_article` WHERE (`id`=744) LIMIT 1 (1 sor: 0,0003 mp/0,0037 mp)
SELECT id FROM `alz_mag_topic` WHERE parent_id = '2' (0 sor: 0,0002 mp/0,0038 mp)
UPDATE `alz_mag_topic`
SET `permalink` = ''
WHERE `id` = (0 sor: 0,0001 mp/0,0039 mp)
SELECT GROUP_CONCAT(keyword) FROM alz_mag_article_keyword WHERE mag_article_id = '744' GROUP BY mag_article_id (0 sor: 0,0004 mp/0,0043 mp)
SELECT permalink FROM alz_mag_category WHERE id = '1' (1 sor: 0,0002 mp/0,0045 mp)
SELECT * FROM alz_mag_category WHERE id IN (1) ORDER BY title (1 sor: 0,0002 mp/0,0046 mp)
SELECT * FROM `alz_core_page` WHERE (`id`=1) LIMIT 1 (1 sor: 0,0002 mp/0,0049 mp)
SELECT pageview
FROM alz_mag_article_pageview
WHERE domain_id = '1' AND mag_article_id = '744' (1 sor: 0,0004 mp/0,0052 mp)
UPDATE alz_mag_article_pageview
SET pageview = pageview + 1
WHERE domain_id = ? AND mag_article_id = ? (1 sor: 0,0003 mp/0,0055 mp)
SELECT * FROM `alz_mag_article` WHERE (`id`=744) LIMIT 1 (1 sor: 0,0003 mp/0,0058 mp)
SELECT id FROM `alz_mag_topic` WHERE parent_id = '2' (0 sor: 0,0002 mp/0,0060 mp)
UPDATE `alz_mag_topic`
SET `permalink` = ''
WHERE `id` = (0 sor: 0,0001 mp/0,0061 mp)
SELECT GROUP_CONCAT(keyword) FROM alz_mag_article_keyword WHERE mag_article_id = '744' GROUP BY mag_article_id (0 sor: 0,0003 mp/0,0064 mp)
SELECT permalink FROM alz_mag_category WHERE id = '1' (1 sor: 0,0002 mp/0,0066 mp)
SELECT * FROM alz_mag_category WHERE id IN (1) ORDER BY title (1 sor: 0,0002 mp/0,0068 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (8 sor: 0,0006 mp/0,0074 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=270) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0077 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=257) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0081 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=108) AND ((option_submenu=1) OR (option_mainmenu=1)) (8 sor: 0,0005 mp/0,0085 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=145) AND ((option_submenu=1) OR (option_mainmenu=1)) (10 sor: 0,0004 mp/0,0090 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=165) AND ((option_submenu=1) OR (option_mainmenu=1)) (12 sor: 0,0004 mp/0,0094 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=202) AND ((option_submenu=1) OR (option_mainmenu=1)) (17 sor: 0,0004 mp/0,0098 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=248) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0101 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=250) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0103 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (0 sor: 0,0002 mp/0,0105 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (0 sor: 0,0003 mp/0,0108 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (8 sor: 0,0003 mp/0,0111 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=109) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0113 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=110) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0115 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=111) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0118 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=112) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0121 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=113) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0123 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=136) AND ((option_submenu=1) OR (option_mainmenu=1)) (4 sor: 0,0003 mp/0,0125 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=114) AND ((option_submenu=1) OR (option_mainmenu=1)) (6 sor: 0,0003 mp/0,0128 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=267) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0130 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (10 sor: 0,0004 mp/0,0134 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=146) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0137 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=147) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0139 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=148) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0141 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=149) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0143 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=116) AND ((option_submenu=1) OR (option_mainmenu=1)) (1 sor: 0,0002 mp/0,0146 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=150) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0148 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=151) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0150 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=152) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0153 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=153) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0155 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=266) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0157 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (12 sor: 0,0005 mp/0,0162 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=166) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0164 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=167) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0167 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=168) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0169 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=169) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0171 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=226) AND ((option_submenu=1) OR (option_mainmenu=1)) (6 sor: 0,0003 mp/0,0174 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=140) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0176 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=242) AND ((option_submenu=1) OR (option_mainmenu=1)) (5 sor: 0,0003 mp/0,0179 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=193) AND ((option_submenu=1) OR (option_mainmenu=1)) (6 sor: 0,0003 mp/0,0182 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=142) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0184 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=144) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0186 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=239) AND ((option_submenu=1) OR (option_mainmenu=1)) (1 sor: 0,0003 mp/0,0188 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=268) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0191 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (17 sor: 0,0006 mp/0,0196 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=203) AND ((option_submenu=1) OR (option_mainmenu=1)) (3 sor: 0,0003 mp/0,0200 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=172) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0202 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=207) AND ((option_submenu=1) OR (option_mainmenu=1)) (4 sor: 0,0003 mp/0,0205 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=171) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0207 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=173) AND ((option_submenu=1) OR (option_mainmenu=1)) (4 sor: 0,0003 mp/0,0211 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=212) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0213 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=178) AND ((option_submenu=1) OR (option_mainmenu=1)) (6 sor: 0,0003 mp/0,0217 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=221) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0219 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=265) AND ((option_submenu=1) OR (option_mainmenu=1)) (3 sor: 0,0003 mp/0,0222 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=222) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0224 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=216) AND ((option_submenu=1) OR (option_mainmenu=1)) (3 sor: 0,0003 mp/0,0227 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=200) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0229 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=224) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0231 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=143) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0003 mp/0,0233 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=225) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0235 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=201) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0237 mp)
SELECT * FROM `alz_core_page` WHERE (`parent_id`=269) AND ((option_submenu=1) OR (option_mainmenu=1)) (0 sor: 0,0002 mp/0,0239 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (0 sor: 0,0003 mp/0,0243 mp)
SELECT * FROM `alz_core_page`
WHERE (`option_submenu` = 1) AND (`parent_id` = ?)
ORDER BY `bearing` DESC,`title` ASC (0 sor: 0,0003 mp/0,0246 mp)
SELECT * FROM `alz_mag_article` WHERE (`id`=744) LIMIT 1 (1 sor: 0,0003 mp/0,0249 mp)
SELECT id FROM `alz_mag_topic` WHERE parent_id = '2' (0 sor: 0,0002 mp/0,0250 mp)
UPDATE `alz_mag_topic`
SET `permalink` = ''
WHERE `id` = (0 sor: 0,0001 mp/0,0251 mp)
SELECT GROUP_CONCAT(keyword) FROM alz_mag_article_keyword WHERE mag_article_id = '744' GROUP BY mag_article_id (0 sor: 0,0003 mp/0,0254 mp)
SELECT permalink FROM alz_mag_category WHERE id = '1' (1 sor: 0,0002 mp/0,0256 mp)
SELECT * FROM alz_mag_category WHERE id IN (1) ORDER BY title (1 sor: 0,0001 mp/0,0257 mp)
SELECT * FROM `alz_core_page` WHERE (`id`=250) LIMIT 1 (1 sor: 0,0002 mp/0,0259 mp)
SELECT * FROM `alz_core_page` WHERE (`id`=248) LIMIT 1 (1 sor: 0,0002 mp/0,0261 mp)
SELECT SQL_CALC_FOUND_ROWS * FROM alz_mag_article
WHERE option_status = 'published'
AND date_publish > 0
AND option_suggest = 1
ORDER BY date_publish DESC
LIMIT 0,5 (0 sor: 0,0024 mp/0,0285 mp)
FUTÁSI IDŐK SQL: 0,0285 mp
Oldal: 0,3451 mp
Andrea\Core\Site.generate(): 0,3071 mp
Andrea\Core\Site.show(): 0,3101 mp
Felejtek.hu
