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Dzidza nezve mashanu matsva madhiragi anouya muna 2020

Dzidza nezve mashanu matsva madhiragi anouya muna 2020Zvinodhaka Info

Kubva 2010 nhamba yemishonga mitsva inobvumidzwa gore rega rega neU.S.Food and Drug Administration (FDA) yakawedzera zvakanyanya, ichivhaira mvumo dzinopfuura makumi matatu neshanu gore rega rega zvichienzaniswa neavhareji epfuura padhuze ne21.Iyi inhau huru kuvarwere, sekuwanika yemishonga mitsva uye zvigadzirwa zvehupenyu kazhinji zvinoreva dzimwe nzira dzekurapa kune vanhu vanozvida zvakanyanya.





Pamishonga mitsva inobvumidzwa gore rega rega, mimwe michina mitsva isina kumbobvira yamboshandiswa, asi mimwe iine hukama (kana isina kufanana neiyo) mimwe mishonga yatovepo uye ichakwikwidza pamusika. Idzi dzekupedzisira dzinowanzo kuve dzichangobva kuwanikwa nekuda kwekupera kwepatent, zvichibvumira kuti dzimwe sarudzo uye generic vhezheni yemishonga itengeswe nekutengesa.



Mishonga inogamuchirwa sei neDFA?

Iyo FDA's Center yeDrug Evaluation uye Tsvagiridzo ( CDER inobata kubvumidza uye kuongorora mishonga mitsva isati yawanikwa kuruzhinji. Zvinoenderana ne FDA , CDER inova nechokwadi chekuti zvese zita rezita uye zvinodhaka zvakajairika zvinoshanda nemazvo, uye kuti hutano hwavo hunodarika njodzi dzavowo.

Maitiro emakambani emishonga anofanirwa kupfuura kuti awane mvumo yeDAA, uyezve vachitanga kutengesa mishonga yavo, yakareba uye yakarongeka. Inogona kutora kusvika makore maviri nehafu kuitira iyo FDA kubvumidza mushonga mutsva, uri pamusoro pemakore vaongorori vanotora kugadzira mushonga uye kumhanyisa kiriniki miedzo. Mune zvimwe zviitiko, senge zvekurapa izvo zvinorapa zvirwere zvinotyisidzira hupenyu, iyo FDA ichakurumidzisa maitiro kuburikidza neKubvumidzwa Kwakakurumidza.

Iko kune nhanho nhatu dzematanho ekubvumidza FDA.



1. Kuongororwa kweiyo mamiriro ezvinhu uye kurapwa kunowanikwa

Iyo FDA inoongorora chirwere kana mamiriro ayo mushonga kana chigadzirwa chakagadzirirwa kurapwa. Mukuita kudaro, inoongororawo ikozvino kurapa kwenzvimbo yemamiriro acho kunyatso kuyera izvo zvinogona kubatsirwa nenjodzi nenjodzi.

2. Kuongororwa kwekubatsira uye njodzi kubva kuchipatara data

Mune akawanda mamiriro, vagadziri vezvinodhaka vanofanirwa kuendesa mhedzisiro yeanenge maviri emakiriniki ekuedzwa. Iyo FDA inoshandisa iyi data kuongorora njodzi uye zvakanakira mushonga.

3. Nzira dzekugadzirisa njodzi

Sezvo zvese zvinodhaka zvine njodzi, zvakakosha kuti vanogadzira zvinodhaka vane hurongwa hwekuzvishandisa. Izvi zvinogona kusanganisira iyo FDA-inogamuchirwa dhizaini yezvinodhaka iyo inonyatso tsanangudza njodzi dzese uye mabhenefiti, pamwe nemaitiro ekuzvidzora, asi inogona zvakare kuwedzera kune zvakadzama uye zvakakwana nzira



Chii chinoitika kana FDA ichibvumira mushonga?

Kana mushonga ukabvumidzwa zvinobudirira kutengeswa neDFA, iyo nguva yainotora kurovera pamusika uye kuwanikwa kune varwere inogona kusiyana zvakanyanya. Kazhinji zvinouya pasi nekukurumidza kuti kambani inogona kugadzira uye kugadzirira zvese zvinodiwa zvekushambadzira zvinhu, kusanganisira kurongedza, dzidzo, uye zvekusimudzira zvinhu izvo zvese zvinopasa mutemo wekubvumidzwa.

Zvichienderana nemushonga chaiwo - semuenzaniso, generic inogona kuenda kumusika nekukurumidza zvakanyanya kupfuura chigadzirwa chitsva, chinogadzirwa - uye zviwanikwa zvekambani yemishonga, mimwe mishonga inowanikwa kutengwa mukati memavhiki ekutenderwa, nepo mamwe achida mwedzi kana kupfuura .

Mishonga mitsva ye2020

Nezvose izvi zviri mupfungwa, hachisi chinhu chidiki chekuti mishonga mitsva yakati wandei ichawanikwa kuvarwere mu2020. Zvimwe, chokwadika, hatisati taziva nezvazvo, sezvo zvichizotenderwa uye kugadzirira kutengeswa pamusoro peanotevera gumi nemaviri. mwedzi. Urwu ndirwo runyorwa rwe mishanu yemishonga mitsva iyo FDA inogamuchirwa mu2019 iyo iri kugadzirirwa kuwanikwa muna 2020.



Oxbreaker (voxelotor)

Izvi mushonga mutsva inoshandiswa kurapa sickle cell anemia, inotyisidzira hupenyu, chirwere cheropa chakagarwa nhaka chinokanganisa masero matsvuku eropa. Masero akaumbwa nejeko anodzivirira okisijeni kubva mukufambiswa zvinobudirira mumuviri wese. Oxbryta inoshanda nekudzivirira iyo yepakati kusagadzikana mukati memasero esero, izvo zvinogona kutungamira mukuwedzera kwakanyanya kudikanwa mumazinga ehemoglobin.

Oxbryta muenzaniso wemushonga wakapihwa Kubvumidzwa Kwakakurumidza munaNovember 25, 2019 . Zvakatora mavhiki maviri chete kuti mushonga uuye kumusika. Kubva muna Zvita 2019, inowanikwa kuti ishandiswe muvarwere vanopfuura makore gumi nemaviri ekuberekwa vane sickle cell anemia. Ichaitwa kuti iwanikwe zvirinyore nekuwedzera kugovera mukati 2020.



Kutorwa kamwe pazuva sehwendefa remuromo, mutengo wenyaya weOxbryta uri $ 10 417 pamwedzi. Inoonekwa sechibudiro chemushonga wechirwere ichi, sezvo ichigadzirisa iyo yakakonzera siketi yesero anemia pane kungogadzirisa zviratidzo.

Brukinsa (zanubrutinib)

Mumwe mushonga wakapihwa wakakurumidza kubvumidzwa ne FDA munaNovember 2019 yaive Brukinsa, mushonga unoshandiswa kurapa vanhu vakuru vane mantle cell lymphoma. Varwere, zvisinei, vanofanirwa kunge vakaedza imwe chete kurapwa vasati vaenda kuBrukinsa.



Anogadzira zvinodhaka BeiGene USA akagamuchira mvumo yeDFA yeBrukinsa uye achakwikwidza nemimwe mishonga inosanganisira yekutanga-kumusika Imbruvica .

Parizvino yakatengwa pamadhora gumi nemazana mapfumbamwe nemazana mapfumbamwe nemakumi mapfumbamwe nemashanu ekuwanisa kwemazuva makumi matatu, Brukinsa inogona kutorwa zuva nezuva kana kaviri pazuva. Mushonga uyu urikuenderera mberi nekuedzwa kwemakiriniki mukuyedza kuwana mvumo yechipiri senzira yekurapa chirwere cheLymphocytic leukemia. BeiGene munguva pfupi yapfuura yakaburitswa data iyo inoratidza kuvimbisa.



Roflumilast

Roflumilast ndiyo generic vhezheni ye Daliresp uye inogona kuwanikwa muna 2020. Mushonga uyu unoshandiswa kurapa varwere vane chirwere chisingaperi chisingachinjike chemapapu (COPD).

Kazhinji, inhau dzakanaka kune vatengi kana generic ikawanikwa, sezvo generic inogona kudzikisa mutengo wemishonga kusvika 85%. Asi, kunyangwe hazvo mugadziri (Breckenridge Pharmaceutical, Inc) akagamuchira tendero yeDAA, hapana vimbiso yekuti ichave iri yekutengesa, nekuda kwekusarudzika kwemishonga uye patent.

Mimwe mishonga dzimwe nguva inoshandiswa kurapa COPD inosanganisira bronchodilators senge Xopenex , corticosteroids senge Flovent , uye mishonga yemubatanidzwa se Symbicort .

RELATED: Mishonga yakajairika yakaita seyakanaka zita-mishonga here?

Yakabatanidzwa cabotegravir uye rilpivirine

Mukutanga kwa2019, ViiV Hutano kuiswa yekutenderwa yavo yemwedzi jekiseni, maviri-mishonga regimen yekurapa varwere vane hutachiona hweHIV-1. Izvi zvakagadzirirwa kukwikwidza neyakajairwa matatu-madhimoni marimu anoshandiswa kurapa hutachiona hweHIV-1. Kuumbwa kwejekiseni kwemwedzi nemwedzi kunoonekwa zvakanyanya zviri nyore nzira yekurapa yevanokodzera varwere, zvichienzaniswa nekutora piritsi zuva nezuva .

Mumashoko akanaka evarwere veHIV, sekureva kwa Fortune , Viiv anotarisira kuti kurapwa kuchabvumidzwa neKudya neDrug Administration nekutanga kwegore rinouya. Paunenge wabvumidzwa, musanganiswa wemushonga unozopihwa zita rechiratidzo.

RELATED: FDA inobvumidza Biktarvy kuti ishandiswe mumatanho eHIV

Rybelsus (semaglutidhi)

Rybelsus mushonga mutsva kubva kuNovo Nordisk, imwe yemakambani epasi rose anotungamira mishonga yeshuga. Mushonga mutsva wakapihwa FDA mvumo yekurapa vanhu vakuru vane mhando 2 chirwere cheshuga mu Gunyana 2019 , uye ikave inowanikwa mukutengesa muna Zvita. Sekugadzira kwekuchinja kwezvinodhaka kubva kuDenmark kuenda kuUS muna 2020, uye vanachiremba vachidzidza zvakawanda nezvekubatsira kwayo, mushonga uyu ungangove unowanikwa zvakanyanya.

Kana iripo, inozopihwa sehwendefa kamwe-zuva nezuva mu3 mg, 7 mg, uye 14 mg doses uye ndiyo yega glucagon-yakaita peptide-1 (GLP-1) receptor agonist mufomu yepiritsi. Chinhu chinoshanda, semaglutide, yatove kuwanikwa mu jekiseni fomu .

Novo Nordisk parizvino arikushanda neinishuwarenzi kuchengetedza kunze-kwehomwe mutengo wevarwere inishuwarenzi kusvika kumadhora gumi pamwedzi; zvisinei, kune mishumo yekuti zvinogona kudhurira varwere kusvika pamadhora mazana manomwe nemakumi mana nematatu ekupa kwemazuva makumi matatu.

RELATED: Chirwere cheshuga nemishonga

Kunyangwe ichi chiri chingori chidimbu chemishonga mitsva inogona kuzotengeswa mu2020, inoratidza zvinhu zvinonakidza zvichauya-zvakanyanya kudiwa, kurapwa kwepamberi kunowanikwa zvirinyore. Kubva pane zvitsva, zvigadzirwa zvitsva, kune mamwe asingadhuri ejeniki, uye dzimwe nzira dzekurapa, iva nechokwadi chekutarisa nachiremba wako panguva ya2020 kuitira kuti mishonga mitsva inoenderana nezvido zvako iwanikwe.