종목토론카테고리
게시판버튼
게시글 제목
미국 FDA 긴급 사용 승인현황
게시글 내용
Coronavirus Disease 2019 (COVID-19) EUA Information
| Date of First EUA Issuance | Most Recent Letter of Authorization (PDF) | Authorized Use 1 | Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) |
|---|---|---|---|
| 06/24/2021 | Actemra (Tocilizumab) (107KB) | For the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). | Healthcare Providers (231KB) Patients, Parents, and Caregivers (47KB) Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (128KB) |
| 05/26/2021 | Sotrovimab (388KB) | For the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. | Healthcare Providers (443KB) Patients, Parents, and Caregivers (140KB) Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (288KB) |
| 03/12/2021 | Propofol‐Lipuro 1% (344KB) | To maintain sedation via continuous infusion in patients greater than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting. 2 | Healthcare Providers (420KB) |
| 02/09/2021 | Bamlanivimab and Etesevimab (344KB) (Reissued February 25, 2021) Pause in distribution of bamlanivimab/etesevimab nationwide (from ASPR and FDA, June 25, 2021) |
For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. | Healthcare Providers (550KB) (updated May 14, 2021) Patients, Parents, and Caregivers (130KB) (updated May 14, 2021)
Dear Healthcare Provider Letter (370KB) Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (267KB) (updated May 19, 2021) Previous ASPR and FDA notices about bamlanivimab/etesevimab |
| 11/21/2020 | REGEN-COV (Casirivimab and Imdevimab) (378KB) (Reissued February 3, 2021, February 25, 2021 and June 3, 2021) | Casirivimab and imdevimab to be administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. | Healthcare Providers (608KB) (updated June 3, 2021)
Patients, Parents, and Caregivers (147KB) (updated June 3, 2021)
Dear Healthcare Provider Letter (567KB) (updated June 3, 2021) Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated June 4, 2021) |
| 11/19/2020 | Baricitinib (Olumiant) in Combination with remdesivir (Veklury) (322KB) | For emergency use by healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). | Healthcare Providers (155KB) |
| 08/23/2020 | COVID-19 convalescent plasma (285KB) (Reissued February 23, 2021 and March 9, 2021) Letter Granting EUA Amendment (June 2, 2021) (107KB) |
For the treatment of hospitalized patients with Coronavirus Disease 2019 (COVID-19) | Healthcare Providers (176KB) Patients and Parents/ Caregivers (124KB) Decision Memorandum (166KB) |
| 08/13/2020 | REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit (92KB) | To be used as a replacement solution only in adult patients treated with continuous renal replacement therapy (CRRT), and for whom regional citrate anticoagulation is appropriate, in a critical care setting |
Healthcare Providers (108KB) Patients and Caregivers (52KB) REGIOCIT package insert for EUA (140KB) |
| 05/08/2020 | Fresenius Kabi Propoven 2% (209KB) | To maintain sedation via continuous infusion in patients older than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting 2 |
Healthcare Providers (288KB) Patients and Parent/Caregivers (39KB) Propoven 2% Wall Chart (2.4MB) |
| 05/01/2020 | Remdesivir for Certain Hospitalized COVID-19 Patients (423KB) (Reissued August 28, 2020, October 1, 2020, and October 22, 2020) | For emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness |
Healthcare Providers (375KB) Patients and Parent/ Caregivers (94KB)
Frequently Asked Questions on the EUA for Veklury (remdesivir) for Certain Hospitalized Patients (194KB) (Updated February 4, 2021) |
제약 부문에 렘데시비르 이후 정식 승인은 아직 없습니다
가장 최근에 약템라(인터루킨 억제재) 승인 허나 이 약도 인공 호흡기 중환자에 한 해 아주 일부분만 사용하도록 제한
현재 임상을 마치고 후보군에 오른 두 가지 약도 인터루킨 억제재로 미국 휴젠사 (엔젤루맙), NRx Pharmaceuticals
현재 미국 FDA 에 긴급 사용 승인 신청 중으로 확인 되었네요
둘 다 인공호흡기에 의존하는 환자들에게 효능을 얼마나 발휘 하는가
마지막 데이타로 미 FDA 검증 중으로 알려져 있습니다
Humanigen이 새로 입원한 COVID-19 환자에게서 lenzilumab™의 효과와 안전성을 입증하는 3단계 무작위 이중 블라인드 위약 통제 연구의 발표를 발표함에 따라 EVERSANA는 상용화 준비를 강화한다.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen's immediate focus is on the development of lenzilumab as a therapy for hospitalized hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.
Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.
휴머니젠은 최신 GM-CSF 중화 및 유전자 녹아웃 플랫폼을 통해 암과 전염병 치료를 위한 임상 및 임상 전 치료법 포트폴리오를 개발하고 있다. 휴머니겐의 즉각적인 초점은 입원 중인 저산소성 COVID-19 환자들을 위한 치료제로서 렌질루맵의 개발에 있다. Humanigen은 최근 대규모 B-세포 림프종 확산에서 상업적으로 이용 가능한 모든 CD19 CAR-T 치료법과 결합된 Lenzilumab의 효능과 안전성을 평가하기 위한 무작위 다중센터 잠재적으로 등록적인 2단계 연구를 시작할 계획을 발표했다.
휴머니젠은 GM-CSF 유전자 녹아웃 기술을 채택해 독성을 억제하는 한편 효능 개선 전략을 활용한 차세대 결합 유전자 편집 CAR-T 치료법도 만드는 데 주력하고 있다. 휴머니겐은 이외에도 다양한 고형암에 대한 독자적인 1등급 EphA3-CAR-T 포트폴리오와 다양한 에도시성 질환에 대한 EMR1-CAR-T 포트폴리오를 자체 개발하고 있다. 휴머니겐은 또한 면역치료에 관여하는 다른 CAR-T, 이중특정 또는 자연킬러(NK) T 세포와 결합하여 (중화 항체로 레질루맵을 사용하거나 GM-CSF 유전자 녹아웃을 통해) GM-CSF 중화 기술의 효과를 탐색하고 있다.모든 유전적 조혈모세포이식(HSCT)을 받는 환자에게 이식 대 숙주 질환(GvHD)을 치료할 수 있습니다. 자세한 내용은 www.humanigen.com을 방문하여 LinkedIn, Twitter 및 Facebook에서 Humanigen을 팔로우하십시오.
NRx Pharmaceuticals Announces Positive Data Results from ZYESAMI™ (Aviptadil) Expanded Access Protocol
- Expanded Access Protocol (EAP) Included 240 ICU Patients Suffering Critical COVID-19 with Respiratory Failure who had Exhausted All Approved Therapies
- Sixty-Five Percent of Patients Receiving ZYESAMI™ (Aviptadil) and Maximal Intensive Care were Alive at 28 Days
- Survival was Higher in those Treated with High Flow Nasal Cannula than those Treated with Mechanical Ventilation (76% vs. 54%)
- Results from EAP are Congruent with the Randomized Control Phase 2b/3 ZYESAMI™ (Aviptadil) Trial Data Submitted to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization (EUA)
- EAP Data to be Submitted to US FDA in Support of EUA Filing
NRx 제약, ZYESAMI™(Aviptadil) 확장 액세스 프로토콜의 긍정적인 데이터 결과 발표
- 승인된 모든 치료법을 모두 사용한 호흡기 장애로 심각한 COVID-19 환자 240명을 포함한 확장 액세스 프로토콜(EAP)
- ZYESAMI™(Aviptadil) 및 Maximal Intensive Care를 받은 환자의 65%가 28일 동안 생존해 있음
- 기계식 인공호흡 처리(76% vs. 54%)보다 고유량 비강 캐뉼라로 처리된 경우 생존율이 더 높았습니다.
- EAP의 결과는 랜덤화 제어 단계 2b/3 ZYESAMI™(Aviptadil)와 일치합니다. 미국 식품의약국(FDA)에 긴급 사용 허가(EUA)를 지원하기 위해 제출된 시험 데이터
- EUA 파일링을 지원하기 위해 미국 FDA에 제출할 EAP 데이터
게시글 찬성/반대
- 4추천
- 1반대
운영배심원의견
운영배심원의견이란
운영배심원(10인 이하)이 의견을 행사할 수 있습니다.
운영배심원 4인이 글 내리기에 의견을 행사하게 되면
해당 글의 추천수와 반대수를 비교하여 반대수가
추천수를 넘어서는 경우에는 해당 글이 블라인드 처리
됩니다.
댓글목록