Provention Bio, Inc. kajeno e phatlalalitse hore kopo e rometsoeng hape ea License ea Biologics License (BLA) bakeng sa teplizumab bakeng sa ho lieha ha lefu la tsoekere la mofuta oa 1 (T1D) ho batho ba kotsing e nkuoe e le karabelo e felletseng ea sehlopha sa 2 lengolong la ketso la Phupu 2021 Tsamaiso ea Lijo le Lithethefatsi ea US (FDA). FDA e fane ka sepheo sa sepheo sa tefiso ea mosebelisi la la 17 Phato, 2022. FDA e kile ea fa teplizumab Breakthrough Therapy Lebitso.
"Re thabetse hore ebe re amohetse Setsi se amohela tlhahiso ea rona ea BLA hape e le karabelo e felletseng ho CRL ea Phupu 2021 mme re thabetse hore ebe re nkile mohato o mong hape oa bohlokoa oa ho fumana tumello ea teplizumab bakeng sa batho ba kotsing ea T1D joalo ka lefu la pele. -ho fetola phekolo ho liehisa ho qala ha lefu lena le fokolisang le le behang bophelo kotsing, "ho boletse Ashleigh Palmer, Co-Founder le CEO oa Provention Bio. "Phatlalatso ea kajeno ke litholoana tsa boitelo bo matla le ho sebetsa ka thata ha sehlopha sa rona, 'moho le litšebelisano tsa rona tse kopanetsoeng le tse hahang le FDA tseo re labalabelang ho tsoela pele ka ts'ebetso e ntseng e tsoela pele ea tlhahlobo."
