Kalafo e Ncha ea Kankere e Phahameng ea tšoelesa ea senya

Accord BioPharma e phatlalalitse kajeno, ka kopanelo le Foresee Pharmaceuticals Co., Ltd., tlhahiso ea US ea CAMCEVI™ (leuprolide) 42mg emulsion ea ente bakeng sa kalafo ea mofetše o tsoetseng pele oa tšoelesa ea senya ho batho ba baholo. US Food and Drug Administration e tjhaelletse monwana Kopo e Ntjha ya Dithethefatsi (NDA) ya CAMCEVI ho tswa ho Foresee Pharmaceuticals ka la 25 Motsheanong, 2021. Ente ya CAMCEVI™ 42 mg e fuwe tumello ya ho kgetheha ho Accord BioPharma naheng ya US bakeng sa kgwebo.

"Tlhahiso ea US ea CAMCEVI e tiisa bohlokoa ba theknoloji ea Foresee ea "Stabilized Injectable Formulation" (SIF) ea bopula-maliboho 'me ke mohato o moholo oa ho phethahatsa morero oa rona oa ho ntlafatsa boemo ba tlhokomelo," ho boletse Dr. Ben Chien, mothehi le Molula-setulo oa Foresee. "Rea tseba hore Accord BioPharma e kopanela sepheong seo sa bohlokoa."

CAMCEVI ke motsoako oa pele oa pele o seng o loketse ho enta oa leuprolide mesylate bakeng sa ente e ka tlase ho letlalo e tlang ka seringe e tlatsitsoeng pele e sa tsoakoe. Phuputsong e bulehileng, e entsoeng ka letsoho le le leng la batho ba baholo ba 137 ba fumaneng 42mg ea CAMCEVI ka Letsatsi la 0 le Beke ea 24, CAMCEVI e fane ka khatello e tsitsitseng ea testosterone ho maemo a castrate ka mor'a ente ea pele, ho tloha Bekeng ea 4 ho ea ho Beke ea 48.1 CAMCEVI ha ea lokela ho sebelisoa bakuli ba nang le hypersensitivity ho GnRH kapa GnRH analogues ka lebaka la ho khoneha ha anaphylactic reactions.1 Litla-morao tse tloaelehileng ka ho fetisisa (≥10%) tse hlahang nakong ea nako ea ho latela nako ea matsatsi a 336 e ne e le mocheso o chesang, khatello ea mali, ts'ebetso ea sebaka sa ente, mafu a holimo a phefumoloho. , bohloko ba mesifa le masapo, mokhathala, le bohloko bo ka holimo.1

"Accord Healthcare esale e fana ka lihlahisoa tsa meriana tsa boleng bo holimo US ho tloha mathoasong a bo-2000. Ka tšebelisano-'moho ena le Foresee ha ho thakholoa CAMCEVI, re thabetse ho tsebisa ka molao Accord BioPharma ka lehare le tsepamisitseng maikutlo ho litlhare tse ikhethang, tse tla feta biology ho tlisa phihlello ea meriana ea boleng bo holimo ho bakuli ho pholletsa le US, "ho boletse Binish. Chudgar, Molula-setulo, Accord Healthcare le Accord BioPharma.

"Theknoloji ea ho bona esale pele e re lumella ho fana ka kalafo bakeng sa mofetše o tsoetseng pele oa tšoelesa ea senya e sebetsang hantle le e loketseng lingaka, ka sering e tlatsitsoeng esale pele e fana ka boitokiso bo bonolo bo lebisang boiphihlelong bo ntlafalitsoeng ba kalafo bakeng sa litsebi tsa bophelo bo botle," ho boletse Chrys Kokino, Mopresidente oa US. BioPharma ho Accord BioPharma. "CAMCEVI e tšoaea mohlala oa bohlokoa oa filosofi ea rona - e fetela ka nģ'ane ho baeloji - ka liketso."

Tlhahisoleseding ea Bohlokoa ea Tšireletseho: CAMCEVI, joalo ka li-agonists tse ling tsa GnRH, e baka keketseho ea nakoana ea litekanyetso tsa testosterone serum nakong ea beke ea pele ea phekolo e ka bakang ho mpefala ha nakoana ha matšoao. Bakuli ba nang le lesapo la mokokotlo oa metastatic le / kapa ba nang le tšitiso ea moroto ba lokela ho shejoa ka hloko nakong ea libeke tse 'maloa tsa pele tsa kalafo. Ho tlalehiloe hyperglycemia le kotsi e eketsehileng ea ho ba le lefu la tsoekere ho banna ba fumanang li-agonists tsa GnRH. Maemo a tsoekere ea mali a lokela ho hlahlojoa le ho laoloa ho latela tloaelo ea hona joale ea bongaka. Kotsi e eketsehileng ea lefu la myocardial infarction, lefu la tšohanyetso la pelo, le stroke li tlalehiloe ka ho sebelisana le li-agonists tsa GnRH. Bakuli ba lokela ho behoa leihlo bakeng sa lefu la pelo le methapo ea mali le ho latela mekhoa ea hona joale ea kliniki. Kalafo ea ho hloka Androgen e ka lelefatsa nako ea QT. Ho tlalehiloe ho ferekana ho bakuli ba fumanang li-agonists tsa GnRH, joalo ka CAMCEVI. Lekola maemo a serum a testosterone ka mor'a ente ea CAMCEVI. Ho ipapisitsoe le liphuputso tsa lithuto tsa liphoofolo le mokhoa oa ts'ebetso, CAMCEVI e ka baka kotsi ea lesea ha e fuoa bakhachane. Liphetoho tse mpe tse atileng haholo (≥10%) nakong ea tatellano e bohareng ea matsatsi a 336 e ne e le ho chesa haholo, khatello ea mali, ts'ebetso ea sebaka sa ente, ts'oaetso e phahameng ea phefumoloho, bohloko ba mesifa le masapo, mokhathala le bohloko lipheletsong.