{"id":3708,"date":"2021-03-29T20:59:31","date_gmt":"2021-03-29T20:59:31","guid":{"rendered":"http:\/\/saniona.com.linux18.curanetserver.dk\/development-process\/"},"modified":"2022-03-28T17:20:37","modified_gmt":"2022-03-28T17:20:37","slug":"utvecklingsprocessen","status":"publish","type":"page","link":"https:\/\/saniona.com\/sv\/var-pipeline\/utvecklingsprocessen\/","title":{"rendered":"Utvecklingsprocessen"},"content":{"rendered":"

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V\u00c5R PIPELINE<\/a><\/h6>\n

Utvecklingsprocessen<\/p>\n<\/div>\n

[\/et_pb_slide][\/et_pb_fullwidth_slider][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” module_class=”flower-section” _builder_version=”4.7.4″ _module_preset=”default” background_color=”rgba(0,0,0,0)” custom_margin=”||||false|false” custom_padding=”14px||16px||false|false” custom_padding_tablet=”” custom_padding_phone=”” box_shadow_style=”preset3″ box_shadow_vertical=”-12px” box_shadow_spread=”-12px”][et_pb_row _builder_version=”4.7.4″ _module_preset=”default” custom_padding=”||5px|||”][et_pb_column type=”4_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_image src=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/01\/Saniona_icon_lg_ltblue_new.png” alt=”Saniona Icon blue” title_text=”Saniona_icon_lg_ltblue_new” align_tablet=”” align_phone=”” align_last_edited=”on|phone” disabled_on=”on|off|off” _builder_version=”4.7.4″ _module_preset=”default” z_index=”-1″ width=”66%” width_tablet=”72%” width_phone=”” width_last_edited=”on|tablet” custom_margin=”-350px||-300px||false|false” custom_margin_tablet=”-280px||-300px||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|tablet” animation_style=”fade” animation_direction=”bottom” animation_duration=”1400ms” animation_delay=”200ms” scroll_rotating_enable=”on” scroll_rotating=”60|84|84|100|0\u00b0|30\u00b0|90\u00b0” module_alignment_tablet=”left” module_alignment_phone=”left” module_alignment_last_edited=”on|tablet” scroll_rotating_tablet=”65|84|84|100|0\u00b0|15\u00b0|90\u00b0” scroll_rotating_phone=”” scroll_rotating_last_edited=”on|tablet”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.7.4″ _module_preset=”default” background_color=”rgba(0,0,0,0)” z_index=”60″ custom_padding=”16px||8px||false|false”][et_pb_row column_structure=”2_5,3_5″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_column type=”2_5″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” header_text_color=”#1d7ecd” header_font_size=”48px” header_line_height=”1.2em” custom_margin=”||0px|||” header_font_size_tablet=”38px” header_font_size_phone=”32px” header_font_size_last_edited=”on|desktop”]<\/p>\n

Hur Saniona f\u00f6r Ut Nya Behandlingar till Patienter med S\u00e4llsynta Sjukdomar<\/h1>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” header_text_color=”#1d7ecd” header_font_size=”48px” header_line_height=”1.2em” header_2_font=”Nunito Sans||||||||” header_2_text_color=”#1d7ecd” header_2_font_size=”30px” header_2_line_height=”1.2em” custom_margin=”||17px|||” header_font_size_tablet=”38px” header_font_size_phone=”32px” header_font_size_last_edited=”on|desktop” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone”]<\/p>\n

Sanionas Engagemang f\u00f6r S\u00e4llsynta Sjukdomar:<\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” text_font_size=”20px” text_line_height=”1.4em” custom_margin=”14px|||||” text_font_size_tablet=”” text_font_size_phone=”18px” text_font_size_last_edited=”on|phone”]<\/p>\n

Det finns mer \u00e4n 7 000 erk\u00e4nda s\u00e4llsynta sjukdomar, trots det finns bara FDA-godk\u00e4nda behandlingar f\u00f6r mindre \u00e4n tio procent av dem.<\/strong> Femtio procent av alla s\u00e4llsynta sjukdomar drabbar barn, och 30 procent av dessa d\u00f6r f\u00f6re fem \u00e5rs \u00e5lder. P\u00e5 grund av detta ofantliga behov av behandlingsalternativ har Saniona beslutat sig f\u00f6r att fokusera p\u00e5 att uppt\u00e4cka, utveckla och leverera innovativa behandlingar f\u00f6r m\u00e4nniskor med s\u00e4llsynta sjukdomar v\u00e4rlden \u00f6ver. Att f\u00f6ra ut nya behandlingar till patienter med s\u00e4llsynta sjukdomar \u00e4r en l\u00e5ngdragen process som kan ta upp till 15 \u00e5r – 2,3 \u00e5r l\u00e4ngre \u00e4n den genomsnittliga utvecklingstiden f\u00f6r behandlingar i allm\u00e4nhet. Det amerikanska l\u00e4kemedelsverket FDA har inr\u00e4ttat incitament f\u00f6r att snabba p\u00e5 processen.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.7.4″ _module_preset=”default” scroll_fade_enable=”on”][et_pb_column type=”4_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” text_font_size=”18px” text_line_height=”1.5em” header_5_font=”Nunito Sans|800|||||||” header_5_text_color=”#ffffff” header_5_font_size=”22px” header_5_letter_spacing=”2px” background_color=”#ffc13f” background_image=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/01\/Saniona_icon_lg_gold.png” custom_padding=”45px|60px|45px|60px|false|false” custom_padding_tablet=”” custom_padding_phone=”30px|30px|30px|30px|false|false” custom_padding_last_edited=”on|phone” border_radii=”on|20px|20px|20px|20px”]<\/p>\n

SNABBA FAKTA<\/h5>\n

FDA kan bevilja s\u00e4rl\u00e4kemedelsklassning (Orphan Drug Designation)<\/strong><\/em> till behandlingar som \u00e4r avsedda f\u00f6r s\u00e4llsynta sjukdomar, vilket definieras som tillst\u00e5nd med f\u00e4rre \u00e4n 200 000 drabbade patienter. Den europeiska l\u00e4kemedelsmyndigheten EMA har ocks\u00e5 m\u00f6jlighet att ge s\u00e4rl\u00e4kemedelsstatus till behandlingar f\u00f6r sjukdomar som drabbar f\u00e4rre \u00e4n 5 av 10 000 personer inom EU. Genom klassningen f\u00e5r l\u00e4kemedlets sponsor r\u00e4tt att ta del av ett antal utvecklingsstimulanser, bland annat skattel\u00e4ttnader och minskade eller slopade ans\u00f6kningsavgifter till FDA respektive EMA.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.7.4″ _module_preset=”default” background_color=”rgba(150,199,240,0.3)” background_enable_image=”off” background_size=”contain” background_position=”top_right” custom_padding=”14px||6px||false|false” animation_style=”fade”][et_pb_row column_structure=”1_4,1_2,1_4″ use_custom_gutter=”on” gutter_width=”2″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_column type=”1_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_image src=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/03\/Saniona_icon_discovery.png” title_text=”Saniona_icon_discovery” show_bottom_space_tablet=”off” show_bottom_space_phone=”” show_bottom_space_last_edited=”on|tablet” align_tablet=”center” align_phone=”” align_last_edited=”on|tablet” _builder_version=”4.7.4″ _module_preset=”default” width=”85%” width_tablet=”40%” width_phone=”60%” width_last_edited=”on|phone” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” text_font_size=”20px” text_line_height=”1.4em” header_3_font_size=”36px” min_height=”137px” custom_margin=”20px|||||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|tablet” text_font_size_tablet=”” text_font_size_phone=”18px” text_font_size_last_edited=”on|phone” header_3_font_size_tablet=”” header_3_font_size_phone=”32px” header_3_font_size_last_edited=”on|phone”]<\/p>\n

Uppt\u00e4ckt<\/h3>\n

Under processen f\u00f6r att uppt\u00e4cka ett l\u00e4kemedel kan man beh\u00f6va g\u00e5 igenom upp till 10 000 substanser<\/strong> innan man lyckas gallra fram fem lovande behandlingsalternativ f\u00f6r sjukdomen ifr\u00e5ga som kan utvecklas vidare<\/strong>.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_image src=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/03\/arrow_yellow_right.png” title_text=”arrow_yellow_right” src_tablet=”” src_phone=”” src_last_edited=”on|tablet” disabled_on=”on|on|off” _builder_version=”4.7.4″ _module_preset=”default” width=”70%” custom_margin=”28px|||||”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.7.4″ _module_preset=”default” background_color=”rgba(150,199,240,0.3)” background_enable_image=”off” background_size=”contain” background_position=”top_right” custom_padding=”1px||6px||false|false” scroll_fade_enable=”on”][et_pb_row column_structure=”1_4,1_2,1_4″ use_custom_gutter=”on” gutter_width=”2″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_column type=”1_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_image src=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/03\/arrow_yellow_left.png” title_text=”arrow_yellow_left” align=”right” disabled_on=”on|on|off” _builder_version=”4.7.4″ _module_preset=”default” width=”70%” custom_margin=”28px|||||”][\/et_pb_image][et_pb_image src=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/02\/Saniona_icon_development.png” title_text=”Saniona_icon_development” disabled_on=”off|off|on” _builder_version=”4.7.4″ _module_preset=”default” width=”85%” width_tablet=”40%” width_phone=”60%” width_last_edited=”on|phone” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.7.4″ _module_preset=”default” border_color_top=”#ffffff”][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” text_font_size=”20px” text_line_height=”1.4em” header_3_font_size=”36px” min_height=”137px” custom_margin=”20px|||||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|tablet” text_font_size_tablet=”” text_font_size_phone=”18px” text_font_size_last_edited=”on|phone” header_3_font_size_tablet=”” header_3_font_size_phone=”32px” header_3_font_size_last_edited=”on|phone”]<\/p>\n

Preklinisk Utveckling<\/h3>\n

De utvalda substanserna<\/strong> genomg\u00e5r ett antal olika tester innan man b\u00f6rjar unders\u00f6ka dem p\u00e5 m\u00e4nniskor. Man skaffar sig bland annat en f\u00f6rst\u00e5else f\u00f6r vilka biverkningar<\/strong> som kan uppst\u00e5 och hur l\u00e4kemedlet ska formuleras<\/strong> (till exempel som tablett, kapsel eller injektion).<\/p>\n

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IND\/CTA-ans\u00f6kan<\/h3>\n

Ett f\u00f6retag l\u00e4mnar in en tillst\u00e5ndsans\u00f6kan f\u00f6r l\u00e4kemedelspr\u00f6vning (Investigational New Drug, IND)<\/em> till FDA med en beskrivning av resultaten fr\u00e5n prekliniska studier och av designen f\u00f6r en klinisk studie d\u00e4r l\u00e4kemedlets s\u00e4kerhet och effekt unders\u00f6ks vidare. Inom EU l\u00e4mnar man in en ans\u00f6kan om klinisk l\u00e4kemedelspr\u00f6vning (Clinical Trial Application, CTA)<\/em>.<\/p>\n

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SNABBA FAKTA<\/h5>\n

Ett f\u00f6retag kan beg\u00e4ra att ett nytt l\u00e4kemedel f\u00e5r genomg\u00e5 p\u00e5skyndad granskning (expedited review) genom olika snabbsp\u00e5rsf\u00f6rfaranden.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.7.4″ _module_preset=”default” background_color=”#ffffff” background_enable_image=”off” background_size=”contain” background_position=”top_right” custom_padding=”2px||6px||false|false” scroll_fade_enable=”on”][et_pb_row column_structure=”1_4,3_4″ use_custom_gutter=”on” gutter_width=”2″ _builder_version=”4.7.4″ _module_preset=”default” custom_padding=”||35px|||”][et_pb_column type=”1_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_image src=”https:\/\/saniona.com\/wp-content\/uploads\/2021\/03\/Saniona_icon_clinicaltrials.png” title_text=”Saniona_icon_clinicaltrials” align_tablet=”center” align_phone=”” align_last_edited=”on|tablet” _builder_version=”4.7.4″ _module_preset=”default” width=”85%” width_tablet=”40%” width_phone=”60%” width_last_edited=”on|phone” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.7.4″ _module_preset=”default”][et_pb_text _builder_version=”4.7.4″ _module_preset=”default” text_font_size=”20px” text_line_height=”1.4em” header_3_font_size=”36px” min_height=”137px” custom_margin=”20px|||||” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”” custom_margin_last_edited=”on|tablet” text_font_size_tablet=”” text_font_size_phone=”18px” text_font_size_last_edited=”on|phone” header_3_font_size_tablet=”” header_3_font_size_phone=”32px” header_3_font_size_last_edited=”on|phone”]<\/p>\n

Kliniska Studier<\/h3>\n

F\u00f6r att en behandling ska godk\u00e4nnas m\u00e5ste den i regel genomg\u00e5 en klinisk pr\u00f6vning i tre faser.<\/strong> I vissa fall kan n\u00e5gra av faserna kombineras (till exempel kombinerad Fas 1 och Fas 2 eller kombinerad Fas 2 och Fas 3). Antalet patienter som ing\u00e5r i en klinisk studie p\u00e5 en s\u00e4llsynt sjukdom kan variera. I Fas 1 \u00e4r antalet patienter vanligen litet (~10) medan Fas 2 och Fas 3 kan omfatta mellan 20 och 100 patienter. F\u00f6r vanliga sjukdomar ing\u00e5r det ofta hundratals eller tusentals patienter i en Fas 3-studie. I m\u00e5nga studier p\u00e5 s\u00e4llsynta sjukdomar f\u00e5r dessutom alla deltagarna pr\u00f6vningsl\u00e4kemedlet eftersom det inte finns n\u00e5gon godk\u00e4nd behandling att j\u00e4mf\u00f6ra med (en s\u00e5 kallad enarmad studie).<\/p>\n

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Fas 1<\/h5>\n

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Det h\u00e4r \u00e4r f\u00f6rsta studien p\u00e5 m\u00e4nniskor, d\u00e4r man utv\u00e4rderar om behandlingen har effekt och letar efter m\u00f6jliga biverkningar.<\/p>\n

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Flera m\u00e5nader<\/em><\/p>\n

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Fas 2<\/h5>\n

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Utv\u00e4rdering av dosering och effekt samt fortsatt \u00f6vervakning av biverkningar.<\/p>\n

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Flera m\u00e5nader upp till tv\u00e5 \u00e5r<\/em><\/p>\n

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Fas 3<\/h5>\n

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Bekr\u00e4fta att behandlingen \u00e4r s\u00e4ker, f\u00f6rdelaktig och har effekt.<\/p>\n

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Ett till fyra \u00e5r<\/em><\/p>\n

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SNABBA FAKTA<\/h5>\n

Saniona samarbetar med patientf\u00f6reningar och intresseorganisationer \u00f6ver hela v\u00e4rlden f\u00f6r att kunna v\u00e4ga in deras perspektiv i utformningen av sin strategi f\u00f6r kliniska pr\u00f6vningar.<\/p>\n

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Ans\u00f6kan om Godk\u00e4nnande<\/h3>\n

F\u00f6r att l\u00e4kemedlet ska godk\u00e4nnas<\/strong> m\u00e5ste f\u00f6retaget l\u00e4mna in en ans\u00f6kan om godk\u00e4nnande f\u00f6r nytt l\u00e4kemedel (New Drug Application, NDA) till FDA eller en ans\u00f6kan om marknadsgodk\u00e4nnande (Marketing Authorisation Application, MAA) till EMA, tillsammans med alla kliniska forskningsdata.<\/p>\n

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Ans\u00f6kan Utreds<\/h3>\n

Tiden fram till godk\u00e4nnande kan variera, men ligger typiskt i intervallet sex till tio m\u00e5nader.<\/strong> F\u00f6rutom att all dokumentation granskas ska myndigheterna ocks\u00e5 godk\u00e4nna produktetiketten, som beskriver f\u00f6ruts\u00e4ttningarna f\u00f6r godk\u00e4nnandet och hur l\u00e4kemedlet b\u00e4st b\u00f6r anv\u00e4ndas. Det g\u00f6rs ocks\u00e5 inspektioner av anl\u00e4ggningarna d\u00e4r l\u00e4kemedlet kommer att tillverkas.<\/p>\n

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Godk\u00e4nnande<\/h3>\n

FDA respektive Europeiska kommissionen<\/strong> godk\u00e4nner l\u00e4kemedlet om det bed\u00f6ms vara effektivt och s\u00e4kert<\/strong> och om f\u00f6rdelarna med det \u00f6verv\u00e4ger riskerna f\u00f6r biverkningar. F\u00f6r vissa f\u00f6retag kan godk\u00e4nnandet villkoras av att man inkommer med en REMS-strategi (Risk Evaluation and Mitigation Strategy) och ger kompletterande rapporter f\u00f6r att s\u00e4kerst\u00e4lla att behandlingens f\u00f6rdelar fortsatt \u00f6verv\u00e4ger riskerna.<\/p>\n

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SNABBA FAKTA<\/h5>\n

Efter godk\u00e4nnandet vidtar en i h\u00f6gsta grad samordnad process d\u00e4r betalare, beslutsfattare, tillhandah\u00e5llare av h\u00e4lso- och sjukv\u00e5rd och andra akt\u00f6rer samverkar f\u00f6r att f\u00f6ra ut behandlingen till patienterna. Saniona \u00e4r fast beslutet att hj\u00e4lpa till att s\u00e4kerst\u00e4lla patienternas tillg\u00e5ng till v\u00e5ra l\u00e4kemedel.<\/p>\n

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Efter Godk\u00e4nnandet<\/h3>\n

Ett f\u00f6retag utf\u00f6r uppf\u00f6ljande \u00f6vervakningsstudier \u2013 \u00e4ven kallat Fas 4 \u2013 efter att l\u00e4kemedlet har b\u00f6rjat s\u00e4ljas p\u00e5 marknaden f\u00f6r att f\u00f6rdjupa f\u00f6rst\u00e5elsen f\u00f6r riskerna och nyttan med behandlingen.<\/strong> Om ny information av betydelse framkommer s\u00e5 uppdateras l\u00e4kemedelsetiketten.<\/p>\n

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  1. U.S. Food & Drug Administration. Rare Diseases at FDA. https:\/\/www.fda.gov\/patients\/rare-diseases-fda.<\/a> Senaste \u00e5tkomst: februari 2021.<\/li>\n
  2. Spotlight on Rare Disease. The Lancet. Februari 2019.<\/li>\n
  3. Tufts Center for the Study of Drug Development. Impact Report. Vol. 20, Nr. 3, maj\/juni 2018.<\/li>\n
  4. U.S. Food & Drug Administration. The Drug Development Process. https:\/\/www.fda.gov\/patients\/learn-about-drug-and-device-approvals\/drug-development-process<\/a>. Senaste \u00e5tkomst: februari 2021.<\/li>\n
  5. Drug Discovery and Development. Britannica. https:\/\/www.britannica.com\/technology\/pharmaceutical-industry\/Obstacles-in-drug-development<\/a>. Senaste \u00e5tkomst: februari 2021.<\/li>\n
  6. Clinical Leader. Rare Disease Patient Recruitment and Retention. https:\/\/www.clinicalleader.com\/doc\/ra-re-disease-patient-recruitment-and-retention-0001#:~:text=For%20a%20clinical%20trial%20enrolling,to%20determine%20pricing%20and%20reimbursement<\/a>. Senaste \u00e5tkomst: februari 2021.<\/li>\n
  7. Europeiska l\u00e4kemedelsmyndigheten. Committee for Orphan Medicinal Products (COMP). https:\/\/www.ema.euro-pa.eu\/en\/committees\/committee-orphan-medicinal-products-comp#:~:text=In%20the%20European%20Union%20(EU,10%2C000%20people%20across%20the%20EU.&text=An%20orphan%20designation%20allows%20a,is%20placed%20on%20the%20market<\/a>. Senaste \u00e5tkomst: februari 2021.<\/li>\n
  8. Europeiska l\u00e4kemedelsmyndigheten. Human regulatory. https:\/\/www.ema.europa.eu\/en\/human-regulatory\/mar-keting-authorisation\/obtaining-eu-marketing-authorisation-step-step<\/a>. Senaste \u00e5tkomst: februari 2021.<\/li>\n<\/ol>\n

    [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

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