2019年3月
專(zhuān)注開(kāi)發(fā)HIV/AIDS藥物的ViiV Healthcare公布新型長(zhǎng)效注射HIV療法(cabotegravir/rilpivirine,CAB/RPV)(每月一次肌肉注射給藥)關(guān)鍵III期臨床研究FLAIR(臨床登記號(hào):NCT02938520),ATLAS (NCT02951052)的48周數(shù)據(jù)。
2019年CROI會(huì)議上公布的FLAIR相關(guān)數(shù)據(jù)顯示:cabotegravir/rilpivirine與HIV復(fù)方藥Triumeq(abacavir/dolutegravir/lamivudine,ABC/DTG/3TC)(多替拉韋/阿巴卡韋/拉米夫定)相比,CAB/RPV在維持HIV-1成人感染者病毒學(xué)抑制方面具有非劣效性(病毒學(xué)抑制率)。
FLAIR臨床研究針對(duì)HIV-1初治患者,最開(kāi)始需要接受DTG/ABC/3TC口服方案誘導(dǎo)治療20周。在16周時(shí)HIV-1 RNA<50拷貝/毫升患者按照1:1比例分為針劑組和繼續(xù)口服方案組,48周時(shí)病毒學(xué)無(wú)應(yīng)答率,HIV-1 RNA≥50拷貝/毫升的患者比例針劑組非劣效于口服方案組(2.1% vs 2.5%);病毒學(xué)抑制率,HIV-1 RNA<50拷貝/毫升的患者比例針劑組非劣效于口服方案組(93.6% vs 93.3%)(265/283 vs264/283)。
雙藥長(zhǎng)效注射制劑,每月一次:cabotegravir長(zhǎng)效制劑(CAB LA)為一款新型整合酶抑制劑(長(zhǎng)效納米混懸液, long-acting nanoformulated)(integrase inhibitor ),rilpivirine長(zhǎng)效制劑(RPV LA)為非核苷類(lèi)逆轉(zhuǎn)錄酶抑制劑(non-nucleoside reverse transcriptase inhibitor )。兩個(gè)單獨(dú)的肌內(nèi)注射藥物,臀部是首選的注?部位。
2019年4月
ViiV Healthcare向美國(guó)FDA遞交新型長(zhǎng)效注射HIV療法(cabotegravir/rilpivirine)新藥上市申請(qǐng)(NDA)。
2019年6月
美國(guó)FDA授予cabotegravir/rilpivirine新藥上市申請(qǐng)(NDA)優(yōu)先審評(píng)(Priority Review)資格。這一操作,將使原本常規(guī)審評(píng)時(shí)間10個(gè)月,縮短為6個(gè)月。批準(zhǔn)日期此前預(yù)計(jì)在2019年12月29日。如果本款療法獲批,將HIV治療從每年給藥365天變?yōu)?2次,大大提高患者的依從性。
2019年12月
ViiV Healthcare在2019年12月21日宣布,收到美國(guó)FDA的完整答復(fù)函(complete response letter ,CRL),HIV長(zhǎng)效cabotegravir/rilpivirine復(fù)方藥物上市申請(qǐng)被拒絕批準(zhǔn)。FDA表示是因?yàn)樵搹?fù)方藥物Chemistry Manufacturing and Controls (CMC)原因。此次被否,跟產(chǎn)品的臨床試驗(yàn)數(shù)據(jù)和安全性無(wú)關(guān)。ViiV Healthcare將與美國(guó)FDA密切溝通,來(lái)完善進(jìn)一步的NDA申請(qǐng)。
2020年3月
3月18日,加拿大衛(wèi)生部(Health Canada)批準(zhǔn)了ViiV Healthcare的Cabenuva®(cabotegravir/rilpivirine)上市,屬于全球范圍內(nèi)首次準(zhǔn)。另外,加拿大批準(zhǔn)了cabotegravir片劑,用于長(zhǎng)效療法的導(dǎo)入治療。
同樣在3月,Cabenuva®(cabotegravir/rilpivirine)的多項(xiàng)臨床結(jié)果發(fā)表在NEJM上。
2020年9月,ViiV Healthcare宣布Cabenuva®(cabotegravir/rilpivirine)在加拿大市場(chǎng)正式推出。期待本款長(zhǎng)效療法給患者帶來(lái)更完善的治療方案。
ViiV Healthcare 艾滋病藥物在研產(chǎn)品線(HIV Pipeline)
附:
Cabotegravir其他名稱(chēng)或代號(hào): 744 LA, CAB, GSK-1265744, GSK1265744, GSK744, GSK744 LA, GSK744 LAP, S-265744, S/GSK1265744, cabotegravir LA, cab等等。下圖為其結(jié)構(gòu)式:
Cabotegravir其他在展開(kāi)的臨床:https://pubchem.ncbi.nlm.nih.gov/compound/54713659#section=Clinical-Trials。
參考:
NMPA/CDE;
藥融圈數(shù)據(jù);
FDA/EMA;
相關(guān)公司公開(kāi)披露;
https://viivhealthcare.com;
https://adisinsight.springer.com/search;
https://viivhealthcare.com/en-gb/our-medicines/medicines-in-development/;
Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. NEJM, DOI: 10.1056/NEJMoa1904398;
https://viivhealthcare.com/en-gb/media/press-releases/2020/march/viiv-healthcare-announces-first-global-regulatory-approval-of-ca/;
UNAIDS. Global HIV & AIDS Statistics — 2019 Fact Sheet. Available at: http://www.unaids.org/en/resources/fact-sheet.Last accessed November 2019;
ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV;
https://viivhealthcare.com/en-gb/media/press-releases/2019/december/complete-response-letter-from-us-fda/;
https://aidsinfo.nih.gov/drugs/513/cabotegravir/0/patient,美國(guó)NIH;
HIV在研新藥,National Institute of Allergy and Infectious Diseases (NIAID)。 NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed March 22, 2019;
ViiV Healthcare 官網(wǎng)。 Medicines in development. https://www.viivhealthcare.com/our-medicines/medicines-in-development.aspx. Accessed March 22, 2019;
https://www.viivhealthcare.com/en-gb/media/press-releases/2019/july/viiv-healthcare-announces-start-of-first-ever-study-to-identify-and-evaluate-approaches-to-implementing-its-once-monthly-injectable-hiv-treatment-in-clinical-practice/;
https://www.viivhealthcare.com/en-gb/media/press-releases/2019/april/viiv-healthcare-submits-new-drug-application-to-us-fda-for-the-first-monthly-injectable-two-drug-regimen-of-cabotegravir-and-rilpivirine-for-treatment-of-hiv/;
GSK1265744 (Cabotegravir, CAB) for named patient/compassionate use in HIV. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US)。 Registered on March 5, 2018. NLM Identifier: NCT03462810. https://www.clinicaltrials.gov/ct2/show/NCT03462810. Accessed March 22, 2019;
http://www.croiconference.org/sites/default/files/posters-2015/554LB.pdf. Accessed March 22, 2019;
Margolis DA, Gonzalez-Garcia J, Stellbrink H-J, et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. The Lancet. 2017;390(10101):1499-1510;
等等。
文章來(lái)源:藥融圈
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