Provention Bio, Inc. nhasi yazivisa kuti yakatumirwazve Biologics License Application (BLA) yeteplizumab yekunonoka kwekiriniki yerudzi rwechirwere cheshuga 1 (T1D) muvanhu vari panjodzi yaonekwa semhinduro yakakwana, yekirasi yechipiri kune tsamba yaChikunguru 2 yakanyorwa. iyo US Food and Drug Administration (FDA). Iyo FDA yakapa mushandisi mubhadharo zuva remusi waNyamavhuvhu 2021, 17. Iyo FDA yakambopa teplizumab Breakthrough Therapy Designation.
"Tinofara kuti takagamuchira kugamuchirwa kweAgency kwekutumirwa kwedu kweBLA semhinduro yakazara kuChikunguru 2021 CRL uye tiri kufara kuti takatora rimwe danho rakakosha pakubvumidzwa kwe teplizumab kune vanhu vari panjodzi yeT1D sechirwere chekutanga. -kugadzirisa kurapa kunonotsa kutanga kwechirwere ichi chinopedza simba uye chinotyisa, "akadaro Ashleigh Palmer, Co-Founder uye CEO weProvention Bio. "Chiziviso chanhasi mhedzisiro yekuzvipira kukuru uye kushanda nesimba kwechikwata chedu, takabatana nekudyidzana kwedu uye kunovaka kudyidzana neFDA izvo isu tinotarisira kuenderera mberi kuburikidza nekuenderera mberi kwekuongorora."
ZVOKUBVA MUNYAYA INO:
- "Tinofara kuti takagamuchira kugamuchirwa kweAgency kwekutumirwa kwedu kweBLA semhinduro yakazara kuChikunguru 2021 CRL uye tiri kufara kuti takatora rimwe danho rakakosha pakubvumidzwa kwe teplizumab kune vari panjodzi veT1D sechirwere chekutanga. -kugadzirisa kurapa kunonotsa kutanga kwechirwere ichi chinopedza simba uye chinouraya,”.
- nhasi yazivisa kuti yakatumirwazve Biologics License Application (BLA) ye teplizumab yekunonoka kwekiriniki yerudzi rwechirwere cheshuga 1 (T1D) muvanhu vari panjodzi yaonekwa seyakazara, yekirasi yechipiri mhinduro kune yaChikunguru 2 chiito tsamba neU.
- “Chiziviso chanhasi mhedzisiro yekuzvipira kukuru uye kushanda nesimba kwechikwata chedu, takabatana nekudyidzana kwedu nekudyidzana kunovaka neFDA izvo isu tinotarisira kuenderera mberi kuburikidza nehurongwa hwekuongorora.
