A recent study published in The Lancet has shed light on the significant effects of Project Orbis participation by Swissmedic, the Swiss Agency for Therapeutic Products, on submission gaps, review times, and drug approval decisions between 2020 and 2022. Project Orbis, initiated by the US Food and Drug Administration (FDA) in 2019, is a collaborative parallel-review program designed to expedite patient access to cancer drugs while allowing regulatory agencies to maintain their decision-making independence.
The study aimed to evaluate the first two years of Project Orbis from Swissmedic’s perspective by comparing submission gaps, review times, approval and consensus decision rates and approved indications between Swissmedic and the FDA for marketing authorization applications (MAAs) in oncology. The analysis included 31 Orbis MAAs and 41 non-Orbis MAAs submitted to Swissmedic from January 1, 2020, to December 31, 2021, with decisions evaluated until June 30, 2022. For a broader context, non-Orbis oncology MAAs submitted and evaluated from January 1, 2009, to December 31, 2018, were also considered.
Project Orbis Reduces Submission Gaps and Review Times for Swissmedic Drug Approvals
The median submission gap was significantly reduced for Orbis MAAs at 33 days compared to 168 days for non-Orbis MAAs (p<0.0001). Swissmedic’s median review time was shorter for Orbis MAAs, at 235.5 days, versus 314 days for non-Orbis MAAs (p=0.0002). Approval rates at Swissmedic were nearly identical between Orbis MAAs (77%) and non-Orbis MAAs (76%). The rate of consensus decisions between Swissmedic and the FDA was slightly higher for Orbis MAAs (81%) compared to non-Orbis MAAs (76%).
Interestingly, Swissmedic’s approval rates were lower for indication extensions than for new active substances, a trend observed in both Orbis and non-Orbis MAAs. Divergent decisions between agencies were mainly noted for indication extensions, highlighting the complexity of these cases. During the pre-Orbis era, Swissmedic approved 88% of MAAs for new active substances, indicating a historically strong approval rate that has been maintained under Project Orbis.
Project Orbis Enhances Swissmedic’s Oncology Drug Approval Speed and Efficiency
The study demonstrates that participation in Project Orbis has led to a significant reduction in submission gaps and review times for oncology applications at Swissmedic. This expedited process is crucial for providing patients with faster access to novel cancer treatments. Additionally, the increased rate of consensus decisions between Swissmedic and the FDA suggests that collaborative efforts through Project Orbis enhance regulatory alignment and decision-making efficiency.
From a broader perspective, these findings underscore the value of international regulatory cooperation in improving the timeliness and effectiveness of drug approvals. By reducing bureaucratic delays and fostering collaborative reviews, initiatives like Project Orbis can play a pivotal role in addressing urgent patient needs, particularly in oncology where timely access to innovative therapies can be life-saving.
Overall, this study highlights the positive impact of Project Orbis on Swissmedic’s regulatory processes, paving the way for further enhancements in global drug approval collaborations. The continuation and expansion of such programs could significantly benefit public health by ensuring that effective treatments reach patients more swiftly.
Resource: The Lancet, May 13, 2024
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