Provention Bio, Inc. lero yalengeza kuti kutumizidwanso kwa Biologics License Application (BLA) kwa teplizumab chifukwa chochedwetsa matenda amtundu woyamba wa shuga (T1D) mwa anthu omwe ali pachiwopsezo kwawonedwa ngati yankho lathunthu, la kalasi 1 ku kalata yochita Julayi 2 yolemba. Bungwe la US Food and Drug Administration (FDA). A FDA adapereka chindapusa cha tsiku la Ogasiti 2021, 17. A FDA adapereka kale dzina la teplizumab Breakthrough Therapy.
"Ndife okondwa kuti bungwe lavomereza kuti BLA yathu itumizidwenso ngati yankho lathunthu ku CRL ya Julayi 2021 ndipo tili okondwa kuti tatenganso gawo lina lofunikira pakuvomerezedwa kwa teplizumab kwa omwe ali pachiwopsezo cha T1D ngati matenda oyamba. -kusintha mankhwala kuti achedwetse kuyambika kwa matendawa ofowoka komanso owopsa, "adatero Ashleigh Palmer, Co-Founder ndi CEO wa Provention Bio. "Kulengeza kwa lero ndi chifukwa cha kudzipereka komanso khama la gulu lathu, molumikizana ndi mgwirizano wathu ndi FDA womwe tikuyembekezera kupitiliza ndikuwunika komwe kukuchitika."
