FDA ewepụtala AbbVie's 3-DAA Hepatitis C Therapy Status Breakthrough
FDA ewepụtala AbbVie's 3-DAA Hepatitis C Therapy Status Breakthrough
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N'ịgbaso nhọpụta ọgwụ "ọgwụgwọ ọganihu" n'oge na-adịbeghị anya nke US Food and Drug Administration (FDA), ụlọ ọrụ na-emepụta ọgwụ AbbVie ekwupụtala na ọgwụgwọ ịba ọcha n'anya C 3-DAA nyere ohere ngwa ngwa maka nkwado.

Nke a bụ "ọgwụgwọ ọganihu" nke abụọ nke FDA họpụtara nke na-elekwasị anya Hepatitis C, nke ọzọ bụ daclatasvir sitere na Bristol-Myers Squibb.

Ọgwụgwọ gụnyere iji ọgwụ atọ nke ụlọ ọrụ mere: ABT-450/r + ABT-267 + ABT-333 nwere ma ọ bụ na-enweghị ribavirin, ọgwụ mgbochi nje na-agwọ ịba ọcha n'anya C.

Nnwale ụlọ ọgwụ nke ndị ọrịa 571 bu ọrịa genotype 1 nke ịba ọcha n'anya C na-eji usoro ọgwụgwọ jikọtara ọnụ gosiri na ọnụ ọgụgụ nzaghachi nje virus dị elu na izu iri na abụọ nke ọgwụgwọ. Ndị sonyere na nnwale ahụ ejirila usoro ọgwụgwọ ndị ọzọ na-eme nke ọma na mbụ ma ọ bụ na-amalitebeghị ọgwụgwọ ọ bụla.

"AbbVie nwere obi ụtọ na FDA enyela Breakthrough Therapy designation ka anyị na-ejikọta 3-DAA na enweghị ribavirin. Anyị na-eche na ọ na-egosipụta ikike nke usoro a dị mkpa na ọgwụgwọ HCV, "ka John M. Leonard, MD kwuru. onye isi osote onye isi ala na onye isi sayensị nke AbbVie. "Amụma HCV anyị bụ otu akụkụ nke pipeline anyị na-aga n'ihu bụ nke lekwasịrị anya n'iwepụta usoro ọgwụgwọ ọhụrụ iji gboo mkpa mpaghara ndị na-enweghị mkpa ụlọ ọgwụ."

Site na ọnụ ọgụgụ nzaghachi na elu 90 pasent maka ndị ọrịa nwere genotype 1 nke ịba ọcha n'anya C, ọgwụ ahụ na-ele anya na ọ ga-eme nke ọma n'imezu ebumnuche njedebe ya nke mkpochapụ nje.

Ọgwụ ọnụ a na-aga n'ihu na-aga n'ihu na-aga n'ihu na-aga n'ihu nke atọ nke ụlọ ọgwụ yana ihe karịrị ndị ọrịa 2,000 na mba 29 karịrị.

Ihe karịrị nde mmadụ 160 gburugburu ụwa bu ọrịa ịba ọcha n'anya C, nke nwere akara ngosi ole na ole ma nwee ike ibute ọrịa imeju siri ike na ọdịda. Enweghị ọgwụ mgbochi maka ịba ọcha n'anya C ugbu a, mana ọtụtụ ọgwụgwọ ọhụrụ nọ na nnwale ụlọ ọgwụ ma ọ bụ na-eche nnabata FDA.

AbbVie bụ azụmaahịa azụmaahịa nke sitere na Abbott na ngwụcha 2012.

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