Provention Bio, Inc.. Hukumar Abinci da Magunguna ta Amurka (FDA). FDA ta sanya ranar burin kuɗin mai amfani na Agusta 1, 1. A baya FDA ta ba da Teplizumab Breakthrough Therapy Designation.
"Mun yi farin cikin samun amincewar Hukumar ta sake gabatar da BLA a matsayin cikakkiyar amsa ga Yuli 2021 CRL kuma muna farin cikin ɗaukar wani muhimmin mataki don yuwuwar amincewar teplizumab ga mutanen da ke cikin haɗarin T1D a matsayin cuta ta farko. -gyara magani don jinkirta farkon wannan cuta mai raɗaɗi da barazanar rayuwa, "in ji Ashleigh Palmer, Co-kafa kuma Shugaba na Provention Bio. "Sanarwar ta yau sakamakon gagarumin sadaukarwa ne da aiki tuƙuru da ƙungiyarmu ta yi, tare da haɗin gwiwar haɗin gwiwa da ma'amala mai ma'ana tare da FDA wanda muke sa ran ci gaba ta hanyar aiwatar da bita."
ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:
- “We are delighted to have received the Agency’s acceptance of our BLA resubmission as a complete response to the July 2021 CRL and are excited to have taken yet another significant step towards the potential approval of teplizumab for at-risk T1D individuals as the first ever disease-modifying therapy to delay the onset of this debilitating and life-threatening disease,”.
- today announced that the resubmitted Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals has been considered a complete, class 2 response to the July 2021 action letter by the U.
- “Today’s announcement is the result of tremendous dedication and hard work by our team, in conjunction with our collaborative and constructive interactions with the FDA which we look forward to continuing through the ongoing review process.
