Koyi game da sababbin magunguna 5 da ke zuwa a cikin 2020

Bayanin Magunguna

Tun daga shekarar 2010 yawan sabbin magunguna da Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da su a kowace shekara ya karu matuka, inda ya ke karbar sama da sabbin yarda 38 a kowace shekara idan aka kwatanta da na baya wadanda suka kusa kusan 21. Wannan babban labari ne ga marasa lafiya, kasancewar samuwar sababbin magunguna da kayan ƙirar halitta yawanci yana nufin ƙarin zaɓuɓɓukan magani ga mutanen da suke buƙatar su sosai.

Daga cikin sababbin magungunan da aka yarda da su kowace shekara, wasu samfura ne na ƙira waɗanda ba a taɓa amfani da su ba, yayin da wasu ke da alaƙa da (idan ba daidai ba) da sauran magungunan da aka riga aka samu kuma za su yi gasa a kasuwa. Latterarshen waɗannan yawanci ana samunsu ne saboda godiya ta ƙare na haƙƙin mallaka, yana ba da damar ƙarin zaɓuɓɓuka da nau'ikan sifofin magungunan da za a sayar da su ta kasuwanci.

Ta yaya FDA ta amince da kwayoyi?

Cibiyar Nazarin Nazarin Magunguna da Bincike ta FDA ( CDER ) shine ke da alhakin amincewa da kimanta sabbin magunguna kafin su samu ga jama'a. A cewar FDA , CDER yana tabbatar da cewa duka alamun suna da magungunan ƙwayoyi suna aiki daidai, kuma fa'idodin lafiyar su sun fi nasu haɗarin.

Dole ne kamfanonin hada magunguna suyi aiki don samun yardar FDA, kuma bi da bi fara sayar da magungunan su, yana da tsayi kuma an tsara shi. Yana iya ɗaukar har zuwa shekara biyu da rabi don FDA ta amince da sabon magani, wanda yake kan shekarun shekarun da masu bincike ke ɗauka don haɓaka ƙwayar magungunan da gudanar da gwaji na asibiti. A wasu lokuta, kamar na hanyoyin kwantar da hankali waɗanda ke magance cututtuka masu barazanar rai, FDA za ta hanzarta aiwatar ta hanyar Amincewa da Sauri.

Akwai matakan matakai guda uku ga tsarin amincewa da FDA.

1. Tattaunawa game da yanayin manufa da magungunan da ake dasu

FDA tana nazarin rashin lafiya ko yanayin da ake nufin maganin ko samfurin don magance shi. A yin haka, yana kuma kimanta yanayin jiyya na halin yanzu don auna amfanin kwayoyi da haɗarin su.

2. Bincike na fa'idodi da haɗari daga bayanan asibiti

A mafi yawancin yanayi, masu yin kwayoyi dole ne su gabatar da sakamakon aƙalla gwajin asibiti biyu. FDA tana amfani da wannan bayanan don kimanta haɗari da fa'idar maganin.

3. Dabarun sarrafa hadari

Kamar yadda dukkan kwayoyi suke da haɗari, yana da mahimmanci masu shan magani suna da shirin sarrafa su. Wannan na iya haɗawa da lakabin magani na FDA wanda aka yarda dashi wanda ke bayyane cikakkun bayanai game da haɗari da fa'idodi, gami da yadda za'a rage su, amma kuma zai iya faɗaɗawa zuwa ƙarin dabaru masu zurfin gaske.

Menene ya faru lokacin da FDA ta amince da magani?

Idan FDA ta sami nasarar amincewa da magani don siyarwa ta FDA, lokacin da zai ɗauki kasuwa da samin wadatar marasa lafiya na iya bambanta sosai. Sau da yawa yakan sauka ne da sauri yadda kamfani zai iya ƙirƙira da shirya duk kayan kasuwancin da ake buƙata, gami da marufi, kayan ilimantarwa, da kayan talla waɗanda duk suna wuce yarda da doka.

Dogaro da takamaiman magani-misali, kwayar halitta takan iya zuwa kasuwa da sauri fiye da sabon, sabon magani, da albarkatun kamfanin magani, ana samun wasu magunguna don sayan tsakanin makonni na amincewa, yayin da wasu ke buƙatar watanni ko sama da haka .

Sabbin magunguna na 2020

Tare da duk wannan a zuciya, ba ƙaramin abin kirki ba ne cewa za a wadatar da sababbin magunguna ga marasa lafiya a cikin 2020. Wasu, ba shakka, ba mu sani ba tukuna, saboda za a amince da su kuma a shirye suke don siyarwa a cikin 12 na gaba. watanni. Wannan jerin sabbin magunguna guda biyar ne da FDA ta amince dasu a shekarar 2019 wadanda ake shirin samar dasu a shekarar 2020.

Oxbreaker (voxelotor)

Wannan sabon magani ana amfani dashi don magance cutar sikila, cutar barazanar rai, cututtukan jini da aka gada wanda ke lalata jajayen ƙwayoyin jini. Kwayoyin sikila masu sikila suna hana isar da iskar oxygen yadda yakamata a cikin jiki. Oxbryta yana aiki ta hana ƙananan rashin lafiya a cikin ƙwayoyin sikila, wanda zai haifar da haɓakar da ake buƙata a matakan haemoglobin.

Oxbryta misali ne na magani wanda aka ba shi celeara Ingantawa a Nuwamba 25, 2019 . Ya ɗauki makonni biyu kawai don maganin ya zo kasuwa. Tun daga watan Disamba 2019, ana iya amfani dashi ga marasa lafiya sama da shekaru 12 tare da cutar sikila. Za'a samar dashi da sauƙin tare da haɓaka rarraba cikin 2020.

An ɗauka sau ɗaya kowace rana a matsayin kwamfutar hannu ta baka, farashin jerin sunayen Oxbryta shine $ 10,417 kowace wata. An yi la'akari da babban magani ne na cutar, saboda yana magance asalin cutar sikila maimakon kula da alamomin kawai.

Brukinsa (zanubrutinib)

Wani magani kuma wanda aka bashi saurin hanzari daga FDA a watan Nuwamba 2019 shine Brukinsa, wani magani ne wanda ake amfani dashi don kula da manya marasa lafiya tare da kwayar cutar kwayar halitta. Marasa lafiya, kodayake, tabbas sun gwada aƙalla wata hanyar maganin kafin canzawa zuwa Brukinsa.

BeiGene Amurka mai shan ƙwaya BeiGene Amurka ta karɓi amincewar FDA don Brukinsa kuma za ta yi gasa tare da sauran magunguna ciki har da kasuwar farko Imbruvica .

A halin yanzu farashin sa ya kai $ 12,935 don samarwa na kwanaki 30, ana iya ɗaukar Brukinsa kowace rana ko sau biyu a rana. Magungunan a halin yanzu yana fuskantar ƙarin gwaji na asibiti a ƙoƙarin samun yarda ta biyu azaman magani ga cutar sankarar bargo ta lymphocytic. BeiGene kwanan nan fito da bayanai wanda ke nuna alkawari.

Roflumilast

Roflumilast sigar gama gari ce ta Daliresp kuma akwai yiwuwar ya kasance a cikin 2020. Ana amfani da miyagun ƙwayoyi don kula da marasa lafiya da ke fama da matsanancin ciwon huhu na huhu (COPD).

Gabaɗaya, labari ne mai kyau ga masu amfani lokacin da kwayar halitta ta samo, kamar yadda kwaya zata iya rage farashin magani har zuwa 85%. Amma, kodayake masana'antun (Breckenridge Pharmaceutical, Inc) sun sami amincewar FDA, babu tabbacin lokacin da za ta zama ta kasuwanci, saboda keɓancewar ƙwayoyi da haƙƙin mallaka.

Sauran kwayoyi wasu lokuta ana amfani dasu don kula da COPD sun hada da masu amfani da bronchodilators kamar Xopenex , corticosteroids kamar su Kashewa , da kuma hada magunguna kamar Symbicort .

Dangantaka: Shin magunguna na yau da kullun suna da kyau kamar magungunan suna?

Hada cabotegravir da rilpivirine

A farkon 2019, ViiV Kiwan lafiya amfani don amincewa da allurar su ta wata-wata, tsarin magunguna biyu don kula da marasa lafiya da ke dauke da kwayar cutar HIV-1. An tsara wannan don yin gasa tare da daidaitattun ƙa'idodin magunguna uku da ake amfani dasu yanzu don magance ƙwayoyin HIV-1. Kirkirar allurar kowane wata ana daukarta sosai dace Zaɓin magani don marasa lafiya waɗanda suka cancanta, idan aka kwatanta da shan a kwaya kwaya .

A cikin kyakkyawan labari ga masu cutar kanjamau, a cewar Arziki , Viiv yana fatan cewa za a amince da maganin ta Cibiyar Abinci da Magunguna ta farkon shekara mai zuwa. Da zarar an yarda, za a ba da magungunan haɗin gwiwa sunan suna.

Dangantaka: FDA ta amince da Biktarvy don amfani da tsarin HIV

Rybelsus (semaglutide)

Rybelsus wani sabon magani ne daga Novo Nordisk, daya daga cikin manyan kamfanonin harhada magunguna na duniya. Sabon likitan ya sami izinin FDA don kula da manya da ciwon sukari na 2 a ciki Satumba 2019 , kuma ya zama akwai kasuwanci a watan Disamba. Yayinda ake kera magungunan daga Denmark zuwa Amurka a 2020, kuma likitoci sun kara koyo game da fa'idodi, mai yiwuwa maganin ya zama yadu.

Idan aka samu, za a bayar da shi azaman kwamfutar hannu sau ɗaya a rana a cikin 3 MG, 7 MG, da kuma 14 MG allurai kuma shine kawai mai karɓar nau'in agcist-like peptide-1 (GLP-1) a cikin kwaya. Sinadarin aiki, semaglutide, ya riga ya kasance a cikin wani injectable tsari .

Novo Nordisk a halin yanzu yana aiki tare da masu inshora don adana kuɗin aljihun marasa lafiya masu inshora zuwa $ 10 kowace wata; duk da haka, akwai rahotanni cewa zai iya kashe marasa lafiya har zuwa $ 772.43 don wadatar kwanaki 30.

Dangantaka: Magungunan ciwon suga da magunguna

Kodayake wannan hoto ne kawai na sababbin magunguna waɗanda zasu iya zama masu kasuwanci a cikin 2020, yana nuna abubuwa masu ban sha'awa da zasu zo-wanda ake buƙata, ingantattun jiyya suna samun wadatar sauƙin. Daga sababbin abubuwa, sababbin abubuwa, zuwa mafi ƙarancin ilimin jinsi, da hanyoyin magance masu sauki, tabbatar da dubawa tare da likitanka yayin 2020 idan sabbin magunguna masu dacewa da buƙatunku sun samu.