Accord BioPharma ta sanar a yau, tare da haɗin gwiwar Foresee Pharmaceuticals Co., Ltd., ƙaddamar da Amurka na CAMCEVI ™ (leuprolide) 42mg allurar emulsion don maganin ciwon daji na prostate a cikin manya. Hukumar Abinci da Magunguna ta Amurka ta amince da Sabuwar Aikace-aikacen Magunguna (NDA) na CAMCEVI daga Foresee Pharmaceuticals a kan Mayu 25, 2021. CAMCEVI™ 42 MG allurar tana da lasisi na musamman ga Accord BioPharma a cikin Amurka don kasuwanci.
"Kaddamar da CAMCEVI na Amurka yana tabbatar da mahimmancin fasaha na fasaha na farko na Foresee Stabilized Injectable Formulation (SIF) kuma mataki ne mai ban mamaki don cika manufarmu na ingantawa akan ma'auni," in ji Dokta Ben Chien, wanda ya kafa kuma shugaban Foresee. "Mun san cewa Accord BioPharma yana da hannun jari a wannan muhimmin burin."
CAMCEVI shine farkon shirye-shiryen allurar bakararre na leuprolide mesylate don allurar subcutaneous wanda ya zo a cikin sirinji da aka riga aka cika ba tare da buƙatar haɗawa ba. A cikin alamar buɗewa, nazarin hannu guda ɗaya na 137 manya waɗanda suka karbi 42mg na CAMCEVI a ranar 0 da mako 24, CAMCEVI ya ba da daidaitattun matakan testosterone zuwa matakan ƙaddamarwa bayan allurar farko, daga Makon 4 zuwa mako 48.1 CAMCEVI bai kamata a yi amfani da shi ba. marasa lafiya tare da hypersensitivity zuwa GnRH ko GnRH analogs saboda yiwuwar halayen anaphylactic.1 Mafi yawan halayen rashin lafiya (≥10%) da ke faruwa a lokacin tsaka-tsaki na tsawon kwanaki 336 sune zafi mai zafi, hauhawar jini, halayen wurin allura, cututtuka na numfashi na sama. , ciwon musculoskeletal, kasala, da zafin jiki.1
"Accord Healthcare yana samar da ingantattun samfuran magunguna a cikin Amurka tun farkon shekarun 2000. Ta hanyar wannan haɗin gwiwa tare da Foresee kan ƙaddamar da CAMCEVI, muna farin cikin ƙaddamar da Accord BioPharma a hukumance tare da mai da hankali sosai kan magunguna na musamman, wanda zai wuce ilimin halitta don kawo ƙarin damar samun magunguna masu inganci ga marasa lafiya a duk faɗin Amurka, "in ji Binish. Chudgar, Shugaban, Accord Healthcare da Accord BioPharma.
"Fasaha na Foresee yana ba mu damar ba da magani ga ciwon daji na prostate mai ci gaba wanda ke da tasiri da kuma dacewa ga masu aiki, tare da sirinji da aka rigaya yana samar da shirye-shirye mai sauƙi wanda ke haifar da ingantacciyar ƙwarewar jiyya ga ƙwararrun kiwon lafiya," in ji Chrys Kokino, Shugaban Amurka. BioPharma a Accord BioPharma. "CAMCEVI alama ce mai mahimmanci misali na falsafancin mu - wucewar ilmin halitta - a aikace."
Muhimmiyar Bayanan Tsaro: CAMCEVI, kamar sauran GnRH agonists, yana haifar da karuwa mai sauƙi a cikin matakan testosterone a cikin makon farko na jiyya wanda zai iya haifar da mummunan cututtuka na wucin gadi. Marasa lafiya tare da raunin kashin baya da / ko tare da toshewar urinary ya kamata a lura da su sosai a cikin makonni na farko na jiyya. An ba da rahoton hyperglycemia da ƙara haɗarin haɓaka ciwon sukari a cikin maza masu karɓar agonists na GnRH. Ya kamata a kula da matakan glucose na jini bisa ga aikin asibiti na yanzu. Ƙara haɗarin ciwon zuciya na zuciya, mutuwar zuciya da sauri, da bugun jini an ruwaito tare da amfani da GnRH agonists. Ya kamata a kula da marasa lafiya don cututtukan zuciya da jijiyoyin jini kuma bisa ga aikin asibiti na yanzu. Maganin hanawar Androgen na iya tsawaita tazarar QT. An ba da rahoton tashin hankali a cikin marasa lafiya da ke karɓar agonists na GnRH, kamar CAMCEVI. Kula da matakan jini na testosterone bayan allurar CAMCEVI. Dangane da binciken da aka yi a cikin nazarin dabbobi da tsarin aiki, CAMCEVI na iya haifar da cutar da tayin lokacin da aka yi wa mata masu ciki. Mafi na kowa (≥10%) mummunan halayen yayin bin tsaka-tsaki na kwanaki 336 sune zafi mai zafi, hauhawar jini, halayen wurin allura, cututtuka na numfashi na sama, ciwo na tsoka, gajiya, da zafi a cikin extremities.
