Funda ngemithi emisha emi-5 eza ngo-2020
Imininingwane YezidakamizwaKusukela ngo-2010 inani lemithi emisha evunyelwe unyaka ngamunye yi-US Food and Drug Administration (FDA) lenyuke kakhulu, ngokwesilinganiso ukuvunywa okusha okungaphezulu kwama-38 unyaka ngamunye uma kuqhathaniswa nezilinganiso zangaphambilini eziseduze nama-21. Lezi yizindaba ezinhle ezigulini, njengoba ukutholakala kwezidakamizwa ezintsha nemikhiqizo yezinto eziphilayo ngokuvamile kusho izindlela eziningi zokwelashwa kubantu abazidinga kakhulu.
Emithini emisha evunywa unyaka nonyaka, eminye yimikhiqizo emisha engakaze isetshenziswe phambilini, kanti eminye ihlobene (uma kungenjalo) neminye imithi esivele ikhona futhi ezoncintisana emakethe. Lezi zokugcina zivame ukutholakala ngenxa yokuphela kwamalungelo obunikazi, okuvumela izinketho eziningi kanye nezinguqulo zemithi ejwayelekile ukuthi zithengiselwe ukuthengisa.
Izidakamizwa zivunywa kanjani yi-FDA?
Isikhungo se-FDA sokuHlola nokuCwaninga ngezidakamizwa ( CDER ) unesibopho sokwamukela nokuhlola imishanguzo emisha ngaphambi kokuba itholakale emphakathini. Ngokusho kwe- I-FDA , i-CDER iqinisekisa ukuthi kokubili igama lomkhiqizo nemithi ejwayelekile isebenza kahle, nokuthi izinzuzo zabo zezempilo zidlula izingozi zabo.
Inqubo yezinkampani ezenza imithi kumele idlule ukuze ithole ukuvunyelwa yi-FDA, bese kuqala ukuthengisa izidakamizwa zayo, yinde futhi yakhiwe. Kungathatha kuze kufike ku- iminyaka emibili nohhafu ukuze i-FDA ivume umuthi omusha, ongaphezulu kweminyaka abacwaningi abayithathayo ukuthuthukisa umuthi nokuqhuba izivivinyo zomtholampilo. Kwezinye izimo, njengezindlela zokwelapha ezelapha izifo ezisongela impilo, i-FDA izosheshisa inqubo ngokugunyazwa okusheshayo.
Kunezigaba ezintathu empeleni zenqubo yokuvunywa kwe-FDA.
1. Ukuhlaziywa kwesimo esihlosiwe kanye nokwelashwa okutholakalayo
I-FDA ihlaziya ukugula noma isimo umuthi noma umkhiqizo ohloselwe ukuselapha. Ngokwenza njalo, ibuye ihlole indawo yokwelashwa yamanje yalesi simo ukukala ngempumelelo izinzuzo nezingozi zomuthi ezingaba khona.
2. Ukuhlolwa kwezinzuzo nobungozi obuvela kudatha yomtholampilo
Ezimweni eziningi, abenzi bezidakamizwa kufanele bahambise imiphumela okungenani emibili yokuhlolwa komtholampilo. I-FDA isebenzisa le datha ukuhlola ubungozi nezinzuzo zomuthi.
3. Amasu okuphatha ubungozi
Njengoba yonke imishanguzo inobungozi, kubalulekile ukuthi abenzi bezidakamizwa babe nohlelo lokuyilawula. Lokhu kungafaka ilebula lezidakamizwa eligunyazwe yi-FDA elichaza ngokusobala zonke izingozi nezinzuzo, nokuthi ungazinciphisa kanjani, kepha futhi lingadlulela kumasu ajule futhi aphelele.
Kwenzekani lapho i-FDA ivuma umuthi?
Uma umuthi uvunywa ngempumelelo ukuthengiswa yi-FDA, isikhathi esisithathayo ukushaya imakethe futhi sitholakale ezigulini singahluka kakhulu. Imvamisa kuya ngokuthi inkampani ingakha futhi ilungiselele masinyane kanjani yonke impahla edingekayo yokumaketha, kufaka phakathi ukupakisha, okokufundisa, kanye nezinto zokwazisa konke okudlulisa ukuvunyelwa komthetho.
Ngokuya ngomuthi othile — ngokwesibonelo, umuthi ojwayelekile ungaya emakethe ngokushesha okukhulu kunomuthi omusha sha, nezinsizakusebenza zenkampani yezidakamizwa, eminye imithi iyatholakala ukuze ithengwe kungakapheli amasonto evunyelwe, kanti eminye idinga izinyanga noma ngaphezulu .
Izidakamizwa ezintsha zango-2020
Ngakho konke lokhu engqondweni, akuyona into encane ukuthi inani lemithi emisha izotholakala ezigulini ngonyaka we-2020. Eminye, vele, asikazi okwamanje, ngoba izovunyelwa futhi ilungele ukuthengiswa eminyakeni eyi-12 elandelayo izinyanga. Lolu uhla lwemithi emihlanu emisha i-FDA evunyelwe ngo-2019 elungiselelwa ukutholakala ngo-2020.
I-Oxbreaker (voxelotor)
Lokhu umuthi omusha isetshenziselwa ukwelapha i-sickle cell anemia, isifo esisongela impilo, nesifo segazi esikhubaza amaseli abomvu egazi. Amaseli amise isikela avimbela umoya-mpilo ekuhanjisweni ngempumelelo kuwo wonke umzimba. I-Oxbryta isebenza ngokuvimbela okungajwayelekile okuphakathi kwamaseli erhengqa, okungaholela ekwandeni okudingeka kakhulu emazingeni e-hemoglobin.
I-Oxbryta iyisibonelo somuthi onikezwe imvume yokuShesha ngoNovemba 25, 2019 . Kuthathe amasonto amabili kuphela ukuthi umuthi ufike emakethe. Kusukela ngoDisemba 2019, iyatholakala ukuthi isetshenziswe ezigulini ezineminyaka engaphezu kwengu-12 ubudala ezine-sickle cell anemia. Izotholakala kalula ngokusatshalaliswa okwandisiwe kuyo yonke i-2020.
Kuthathiwe kanye nsuku zonke njengethebhulethi yomlomo, intengo yohlu luka-Oxbryta ingu- $ 10,417 ngenyanga. Kubhekwa njengesidakamizwa sokuqhamuka kwalesi sifo, njengoba silapha imbangela yomsuka we-sickle cell anemia kunokulawula nje izimpawu.
I-Brukinsa (zanubrutinib)
Esinye isidakamizwa esinikezwe imvume esheshayo yi- I-FDA ngoNovemba 2019 kwakunguBrukinsa, umuthi osetshenziselwa ukwelapha iziguli ezindala ezine-mantle cell lymphoma. Iziguli, noma kunjalo, kufanele ukuthi zazama okungenani enye indlela yokwelashwa ngaphambi kokushintshela eBrukinsa.
Umenzi wezidakamizwa uBeiGene USA uthole imvume ye-FDA yeBrukinsa futhi uzoncintisana neminye imishanguzo kubandakanya nemakethe yokuqala. Imbruvica .
Njengamanje kunentengo engu- $ 12,935 yokuthengwa kwezinsuku ezingama-30, iBrukinsa ingathathwa nsuku zonke noma kabili ngosuku. Lo muthi njengamanje usaqhubeka nokuhlolwa kwemitholampilo ngomzamo wokuthola ukuvunywa kwesibili njengokwelashwa kwe-leukemia engapheli ye-lymphocytic. BeiGene muva nje idatha ekhishwe okukhombisa isithembiso.
Roflumilast
I-Roflumilast inguqulo ejwayelekile ye- I-Daliresp futhi kungenzeka utholakale ngo-2020. Lesi sidakamizwa sisetshenziselwa ukwelapha iziguli ezinesifo esingelapheki sokuvuvukala kwamaphaphu (COPD).
Ngokuvamile, kuyizindaba ezimnandi kubathengi lapho kutholakala i-generic, njengoba i-generic inganciphisa izindleko zemithi kufika kuma-85%. Kepha, yize umkhiqizi (uBreckenridge Pharmaceutical, Inc) athola ukuvunywa kwe-FDA, asikho isiqinisekiso sokuthi izotholakala nini ngentengiso, ngenxa yokhetho lwezidakamizwa namalungelo obunikazi.
Ezinye izidakamizwa kwesinye isikhathi ezisetshenziselwa ukwelapha i-COPD zifaka ama-bronchodilators afana Elaphonex , ama-corticosteroids afana ne- I-Flovent , kanye nezidakamizwa ezihlanganisiwe njenge I-Symbicort .
OKUSHIWO: Ingabe imithi ejwayelekile ifana nemithi enegama lomkhiqizo?
I-cabotegravir ehlanganisiwe ne-rilpivirine
Ekuqaleni kuka-2019, i-ViiV Healthcare kusetshenzisiwe ukwamukelwa komjovo wabo ojova njalo ngenyanga, wemithi emibili yokwelapha iziguli ezine-HIV-1. Lokhu kwenzelwe ukuqhudelana nemithi ejwayelekile yemithi emithathu esetshenziselwa ukwelapha ukutheleleka nge-HIV-1. Ukwakhiwa komjovo wanyanga zonke kubhekwa njengokuningi kakhulu elula inketho yokwelashwa kweziguli ezifanelekile, uma kuqhathaniswa nokuthatha i- iphilisi nsuku zonke .
Ezindabeni ezimnandi ezigulini ze-HIV, ngokusho kwe- Inhlanhla , UViiv unethemba lokuthi ukwelashwa kuzokwamukelwa yi-Food and Drug Administration ekuqaleni konyaka ozayo. Uma sekuvunyelwe, umuthi ohlangene uzonikezwa igama lomkhiqizo.
OKUSHIWO: I-FDA igunyaza i-Biktarvy ukuthi isetshenziswe kuma-HIV regimens
I-Rybelsus (semaglutide)
I-Rybelsus yisidakamizwa esisha esivela kwaNovo Nordisk, enye yezinkampani zemithi ezihamba phambili ezigxile kushukela emhlabeni. Umuthi omusha unikezwe imvume ye-FDA yokwelapha abantu abadala abanesifo sikashukela sohlobo 2 Septhemba 2019 , futhi yatholakala ngokuhweba ngoDisemba. Njengoba kwenziwa ukuguquka kwezidakamizwa kusuka eDenmark kuya eU.S ngo-2020, nodokotela befunda kabanzi ngezinzuzo zayo, lo muthi kungenzeka utholakale kabanzi.
Uma itholakala, izonikezwa njengethebhulethi yansukuzonke ku-3 mg, 7 mg, naku-14 mg doses futhi ukuphela kwe-glucagon-like peptide-1 (GLP-1) receptor agonist esefomini lepilisi. Isithako esisebenzayo, i-semaglutide, sesivele siyatholakala ku- ifomu elinomjovo .
UNovo Nordisk njengamanje usebenza nabashuwalense ukugcina izindleko ezingaphandle kwezikhwama zeziguli ezinomshwalense ziye ku- $ 10 ngenyanga; kodwa-ke, kunemibiko yokuthi kungabiza iziguli kuze kufike ku- $ 772.43 ngokunikezwa kwezinsuku ezingama-30.
OKUSHIWO: Imithi yesifo sikashukela kanye nokwelashwa
Yize lesi kuyisifinyezo nje semithi emisha engase itholakale ngokuhweba ngo-2020, ikhombisa izinto ezithokozisayo ezizayo — okudingeka kakhulu, ukwelashwa okuthuthukile okutholakala kalula. Kusuka emikhiqizweni emisha, emisha, kuya kuma-generic athengeka kalula, kanye nezinye izindlela zokwelashwa ezilula, qiniseka ukuthi ungena nodokotela wakho ngonyaka we-2020 uma kwenzeka kutholakala imithi emisha efanele izidingo zakho.
