Ukwelashwa Kokuqala Kokuguqula Izifo Kohlobo Lokuqala Lwesifo Sikashukela

I-Provention Bio, Inc. namuhla imemezele ukuthi isicelo esithunyelwe kabusha se-Biologics License Application (BLA) se-teplizumab sokubambezeleka kwesifo sikashukela sohlobo 1 (T1D) kubantu abasengozini sithathwe njengempendulo ephelele, yekilasi 2 encwadini yesenzo kaJulayi 2021 ka-17. I-US Food and Drug Administration (FDA). I-FDA inikeze idethi yenhloso yenkokhelo yomsebenzisi yangomhla ka-Agasti 2022, XNUMX. I-FDA ngaphambilini yanikeza i-teplizumab Breakthrough Therapy Designation.

“Siyajabula ukuthola i-Ejensi yokwamukela ukuthunyelwa kwethu kabusha kwe-BLA njengempendulo ephelele ku-CRL kaJulayi 2021 futhi sijabule ngokuthi sithathe esinye isinyathelo esibalulekile ekuvunyweni okungaba khona kwe-teplizumab kubantu abasengozini ye-T1D njengesifo sokuqala ngqa. -ukulungisa ukwelapha ukuze kubambezeleke ukuqala kwalesi sifo esiwohlozayo nesisongela ukuphila,” kusho u-Ashleigh Palmer, uMsunguli kanye noMphathi Omkhulu weProvention Bio. “Isimemezelo sanamuhla siwumphumela wokuzinikela okukhulu nokusebenza kanzima kwethimba lethu, ngokubambisana nokusebenzisana kwethu nokwakhana ne-FDA esibheke ngabomvu ukuqhubeka nenqubo yokubuyekeza eqhubekayo.”