Abstract：
BACKGROUND: Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss Agency for Therapeutic Products) has been participating in Project Orbis, a collaborative parallel-review programme launched by the US Food and Drug Administration (FDA) in 2019 to expedite patient access to cancer drugs. This programme allows regulatory agencies to remain independent in their decisions. We aimed to evaluate the effect of the first 2 years of Project Orbis from the Swissmedic perspective.
METHODS: In this comparative analysis, we compared submission gap (time between submission at the FDA and Swissmedic), review time, approval and consensus decision rate, and the approved indications between Swissmedic and the FDA for marketing authorisation applications (MAAs) in oncology submitted to Swissmedic through Project Orbis (Orbis MAAs) or outside of Project Orbis (non-Orbis MAAs) from Jan 1, 2020, to Dec 31, 2021. Swissmedic review time was evaluated with a decision until June 30, 2022. For the decision comparison analysis, non-Orbis oncology MAAs submitted and evaluated from Jan 1, 2009, to Dec 31, 2018 (referred to as the pre-Orbis era) were also considered. Inferential statistics were done using Wilcoxon rank-sum test and the 95% CI for the median was based on binomial distribution. For each hypothesis testing, the significance level was set to 5%. No correction for multiple testing was performed.
RESULTS: We analysed the submission gap, review time, and regulatory decision for 31 Orbis MAAs and 41 non-Orbis MAAs during the Orbis era. The median submission gap was 33·0 days (95% CI 19·0-57·0) for Orbis MAAs versus 168·0 days (56·0-351·0) for non-Orbis MAAs (p<0·0001). The median review time at Swissmedic was 235·5 days (198·0-264·0) for Orbis MAAs versus 314·0 days (279·0-354·0) for non-Orbis MAAs (p=0·0002). Approval rates at Swissmedic were consistent between Orbis MAAs (20 [77%] of 26) and non-Orbis MAAs (31 [76%] of 41). The rate of consensus decisions between Swissmedic and the FDA was 21 (81%) of 26 for Orbis MAAs and 31 (76%) of 41 for non-Orbis MAAs. Swissmedic approval rates were lower for indication extensions than for new active substances for Orbis MAAs (13 [72%] of 18 vs seven [88%] of eight) and non-Orbis MAAs (17 [71%] of 24 vs 14 [82%] of 17). Divergent decisions between agencies were predominantly observed for indication extensions (11 [73%] of 15 divergent decisions). During the pre-Orbis era, Swissmedic approved 61 (88%) of 69 MAAs for new active substances.
CONCLUSIONS: Submission gap and review time for oncology applications at Swissmedic were significantly reduced by participation in Project Orbis, and approval consensus decisions were increased between agencies. These findings suggests that participating in Project Orbis could lead to faster patient access to drugs.
BACKGROUND: None.
METHODS: In this comparative analysis, we compared submission gap (time between submission at the FDA and Swissmedic), review time, approval and consensus decision rate, and the approved indications between Swissmedic and the FDA for marketing authorisation applications (MAAs) in oncology submitted to Swissmedic through Project Orbis (Orbis MAAs) or outside of Project Orbis (non-Orbis MAAs) from Jan 1, 2020, to Dec 31, 2021. Swissmedic review time was evaluated with a decision until June 30, 2022. For the decision comparison analysis, non-Orbis oncology MAAs submitted and evaluated from Jan 1, 2009, to Dec 31, 2018 (referred to as the pre-Orbis era) were also considered. Inferential statistics were done using Wilcoxon rank-sum test and the 95% CI for the median was based on binomial distribution. For each hypothesis testing, the significance level was set to 5%. No correction for multiple testing was performed.
RESULTS: We analysed the submission gap, review time, and regulatory decision for 31 Orbis MAAs and 41 non-Orbis MAAs during the Orbis era. The median submission gap was 33·0 days (95% CI 19·0-57·0) for Orbis MAAs versus 168·0 days (56·0-351·0) for non-Orbis MAAs (p<0·0001). The median review time at Swissmedic was 235·5 days (198·0-264·0) for Orbis MAAs versus 314·0 days (279·0-354·0) for non-Orbis MAAs (p=0·0002). Approval rates at Swissmedic were consistent between Orbis MAAs (20 [77%] of 26) and non-Orbis MAAs (31 [76%] of 41). The rate of consensus decisions between Swissmedic and the FDA was 21 (81%) of 26 for Orbis MAAs and 31 (76%) of 41 for non-Orbis MAAs. Swissmedic approval rates were lower for indication extensions than for new active substances for Orbis MAAs (13 [72%] of 18 vs seven [88%] of eight) and non-Orbis MAAs (17 [71%] of 24 vs 14 [82%] of 17). Divergent decisions between agencies were predominantly observed for indication extensions (11 [73%] of 15 divergent decisions). During the pre-Orbis era, Swissmedic approved 61 (88%) of 69 MAAs for new active substances.
CONCLUSIONS: Submission gap and review time for oncology applications at Swissmedic were significantly reduced by participation in Project Orbis, and approval consensus decisions were increased between agencies. These findings suggests that participating in Project Orbis could lead to faster patient access to drugs.
BACKGROUND: None.
摘要：
背景：新的和有效的药物快速进入市场是有保证的。自2020年以来，Swissmedic（瑞士治疗产品机构）一直参与Orbis项目，美国食品和药物管理局（FDA）于2019年启动的一项合作平行审查计划，旨在加快患者获得癌症药物。该计划允许监管机构在决策中保持独立性。我们旨在从Swissmedic的角度评估Orbis项目前两年的效果。
方法：在此比较分析中，我们比较了提交差距(在FDA和Swissmedic提交之间的时间)，审查时间,批准和共识决定率，从2020年1月1日至2021年12月31日，Swissmedic和FDA之间通过Orbis项目（OrbisMAAs）或Orbis项目之外（非OrbisMAAs）提交的肿瘤学上市许可申请（MAAs）的批准适应症。Swissmedic审查时间的评估决定直到2022年6月30日。对于决策比较分析，还考虑了从2009年1月1日至2018年12月31日提交并评估的非Orbis肿瘤学MAAs(称为Orbis前时代).使用Wilcoxon秩和检验进行推断统计，中位数的95％CI基于二项分布。对于每个假设检验，显著性水平设定为5%.没有进行多次测试的校正。
结果：我们分析了提交差距，审查时间,以及Orbis时代31个OrbisMAAs和41个非OrbisMAAs的监管决定。OrbisMAAs的中位提交间隔为33·0天（95％CI19·0-57·0），非OrbisMAAs的中位提交间隔为168·0天（56·0-351·0）（p<0·0001）。在Swissmedic中，OrbisMAAs的中位审查时间为235·5天（198·0-264·0），而非OrbisMAAs的中位审查时间为314·0天（279·0-354·0）（p=0·0002）。Swissmedic的批准率在OrbisMAAs（26个中的20[77%]）和非OrbisMAAs（41个中的31个[76%]）之间是一致的。Swissmedic和FDA之间的共识决策率为OrbisMAAs的26个中的21个（81％），非OrbisMAAs的41个中的31个（76％）。瑞士医师的适应症扩展批准率低于OrbisMAAs的新活性物质（18中的13[72％]比8中的7[88％]）和非OrbisMAAs（24中的17[71％]比17中的14[82％]）。对于适应症扩展，主要观察到机构之间的分歧决定（15个分歧决定中有11个[73％]）。在奥比斯之前的时代,Swissmedic批准了69种MAAs中的61种（88％）用于新的活性物质。
结论：参与Orbis项目后，瑞士肿瘤学应用的提交差距和审查时间显著缩短，机构之间增加了批准共识决定。这些发现表明，参与Orbis项目可能会导致患者更快地获得药物。
背景：无。
方法：在此比较分析中，我们比较了提交差距(在FDA和Swissmedic提交之间的时间)，审查时间,批准和共识决定率，从2020年1月1日至2021年12月31日，Swissmedic和FDA之间通过Orbis项目（OrbisMAAs）或Orbis项目之外（非OrbisMAAs）提交的肿瘤学上市许可申请（MAAs）的批准适应症。Swissmedic审查时间的评估决定直到2022年6月30日。对于决策比较分析，还考虑了从2009年1月1日至2018年12月31日提交并评估的非Orbis肿瘤学MAAs(称为Orbis前时代).使用Wilcoxon秩和检验进行推断统计，中位数的95％CI基于二项分布。对于每个假设检验，显著性水平设定为5%.没有进行多次测试的校正。
结果：我们分析了提交差距，审查时间,以及Orbis时代31个OrbisMAAs和41个非OrbisMAAs的监管决定。OrbisMAAs的中位提交间隔为33·0天（95％CI19·0-57·0），非OrbisMAAs的中位提交间隔为168·0天（56·0-351·0）（p<0·0001）。在Swissmedic中，OrbisMAAs的中位审查时间为235·5天（198·0-264·0），而非OrbisMAAs的中位审查时间为314·0天（279·0-354·0）（p=0·0002）。Swissmedic的批准率在OrbisMAAs（26个中的20[77%]）和非OrbisMAAs（41个中的31个[76%]）之间是一致的。Swissmedic和FDA之间的共识决策率为OrbisMAAs的26个中的21个（81％），非OrbisMAAs的41个中的31个（76％）。瑞士医师的适应症扩展批准率低于OrbisMAAs的新活性物质（18中的13[72％]比8中的7[88％]）和非OrbisMAAs（24中的17[71％]比17中的14[82％]）。对于适应症扩展，主要观察到机构之间的分歧决定（15个分歧决定中有11个[73％]）。在奥比斯之前的时代,Swissmedic批准了69种MAAs中的61种（88％）用于新的活性物质。
结论：参与Orbis项目后，瑞士肿瘤学应用的提交差距和审查时间显著缩短，机构之间增加了批准共识决定。这些发现表明，参与Orbis项目可能会导致患者更快地获得药物。
背景：无。
