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FDA ta Amince da Gwajin Ciwon Ciwon Hankali Mai Raɗaɗi

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Direct Biologics ta sanar a yau cewa FDA ta amince da kamfanin don ci gaba da gwajin gwajin asibiti na Mataki na 3 ta amfani da maganin sa na EV, ExoFlo, don magance Cutar Cutar Cutar Cutar Cutar (ARDS) saboda Covid-19. Direct Biologics shine kamfani na farko kuma shine kawai kamfanin EV da ya karɓi izinin FDA Phase 3 don nunin Sabon Magani (IND) zuwa yau.  

Za a gudanar da gwaji na Mataki na 3 a ƙarƙashin ingantacciyar ƙididdiga ta Farko ta Regenerative Medicine Advanced Therapy (RMAT) wanda FDA ta amince da shi don maganin EV, wanda ke sa Direct Biologics ɗaya daga cikin kamfanoni 70 kawai a tarihin FDA don an ba da RMAT a hukumance. . Kamar saurin waƙa da ƙayyadaddun ƙira, FDA ta ƙirƙira RMAT don hanzarta amincewa ga magunguna masu haɓakawa waɗanda ke nuna ikon magance cututtukan da ke barazanar rayuwa. 

"Karbar amincewar FDA don Mataki na 3 shine mabuɗin ci gaba ga Direct Biologics," in ji Mark Adams, Co-Founder da Shugaba. "Haɗe tare da nadi na RMAT, yanzu muna kan hanyar haɓakawa zuwa kasuwanci tare da yuwuwar maganin ceton rai-ExoFlo. Wannan gwaji na Mataki na 3 mai taken "Kashe Covid-19" na ƙasa da ƙasa ne, cibiyar sadarwa da yawa, makafi biyu, bazuwar, gwajin lokaci na 3 mai sarrafa wuribo. Manufarmu ita ce rajistar marasa lafiya tare da ARDS a wuraren asibitoci a duk faɗin Amurka, Spain, Indiya, Jordan, Masar, Lebanon, da Afirka ta Kudu, kuma don nuna raguwar mace-mace mai mahimmanci bayan jiyya tare da ExoFlo idan aka kwatanta da daidaitattun kulawa kaɗai. A matsayinmu na majagaba a fagen sabunta hanyoyin kwantar da hankali na likitanci, mu a Direct Biologics muna canza makomar likitanci. ” 

"Ko Covid-19 ya kasance annoba ko kuma ya zama annoba, yanki ɗaya na buƙatun da ba a biya ba ya kasance iri ɗaya: ingantaccen magani ga ARDS. Mutanen da suka haura shekaru 65 da wadanda ke da cututtukan cututtuka, da zarar sun kamu da SARS-CoV-2, koyaushe za su kasance masu rauni ga ci gaba zuwa kamuwa da cuta mai tsanani da ARDS, ”in ji Joe Schmidt, Co-kafa kuma Shugaban kasa. "Bayyana ingantaccen aminci da raguwar mace-mace na kwanaki 60, gwajinmu na Mataki na 2 ya nuna cewa ExoFlo na iya yin babban bambanci na ceton rai ga marasa lafiya da ke asibiti tare da ARDS. Samun amincewar FDA don ci gaba zuwa Mataki na 3 babban nasara ce saboda babu sanannun magani ga ARDS. Likitoci da marasa lafiya a duk faɗin duniya sun daɗe suna jiran mafita."  

"Aiki don haɓaka ExoFlo wata dama ce," in ji Dokta Vik Sengupta, Babban Jami'in Lafiya. "Ƙungiyoyin da ke haɓaka bayanan asibiti sun nuna cewa ExoFlo magani ne wanda ke ba da bege ga maganin cutar wanda tsarin kulawa bai inganta ba a cikin shekarun da suka gabata. Wannan bege ya fi kama da labarun marasa lafiya waɗanda suka karɓi ExoFlo don magani. A makon da ya gabata, wata mata a Virginia ta sake saduwa da 'ya'yanta bayan ta yi fama da injin iska na tsawon watanni 2 saboda haɓakar ARDS da Covid-19 ya jawo. Amma a yunƙurin ƙarshe na ceton rayuwar majiyyaci, likitocin ICU sun nemi a yi mata maganin ExoFlo a cikin tausayawa, kuma ta sami mu'ujiza ta mu'ujiza. Akwai miliyoyin mutane irinta da basu taba fita daga asibiti ba. Muna son canza wannan labarin ta hanyar kafa ExoFlo a matsayin ma'aunin gwal na ARDS da kuma sanya shi isa ga marasa lafiya a asibitoci a duniya. "

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edita

Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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