Drug development—it’s a lengthy and complex journey, one that includes multiple stages of research, testing, and regulatory review. Central to this process are key meetings with the FDA, which ensure new drugs are safe and effective before reaching the market. One crucial milestone is the End of Phase 2 (EOP2) meeting, a pivotal checkpoint that all drug developers must hurdle to advance their products to the next phase of clinical trials.
The EOP2 meeting marks a significant point in the drug development timeline—before moving to Phase 3 and onto the critical next step that Phase 3 clinical trials offer, the EOP2 meeting allows sponsors the opportunity to engage directly with the FDA and receive crucial feedback and alignment on the next stages of development. Its primary goals include:
Central to the EOP2 meeting is the discussion of study design, dose justification, and endpoint selection to ensure upcoming Phase 3 trials provide definitive support for efficacy and safety. This meeting helps sponsors avoid costly mistakes and delays that can arise from inadequate planning. Opting for an EOP2 meeting can significantly boost your NDA approval rates compared to skipping this step. Think of this as your chance to prove your concept works and get the FDA's alignment with your development plan.
The EOP2 meeting typically occurs immediately following the receipt of Phase 2 trial data. It is crucial to present robust clinical data and proof of concept at this stage. Summary efficacy and safety data from the Phase 2 trial should be available for the Review Division in the EOP2 briefing document. A lack of Phase 2 data will render the EOP2 meeting premature and may lead to an ineffective interaction with the Agency. The primary goals are to obtain FDA agreement on the Phase 3 trial design and objectives, ensuring clarity on all aspects of the planned Phase 3 trial.
End of Phase 2 or pre-Phase 3 meetings are Type B (EOP) meetings, which have a unique timeline for meeting request and briefing document submission. An EOP2 meeting is typically scheduled for 70 days following the submission of a meeting request, with the meeting briefing document required to be submitted no later than 50 days before the scheduled date of the meeting or WRO response time. If the FDA schedules a Type B (EOP) meeting sooner than 70 days from the meeting request submission, the meeting briefing document will be due no sooner than 6 calendar days after the FDA issues the letter granting the meeting. As there are typically only 20 days between submission of the meeting request and submission of the meeting briefing document, it is essential to have a nearly complete meeting briefing document at the time the meeting request is submitted. If the sponsor is unable to meet the timeline for submission of the meeting briefing document, the FDA may cancel the meeting.
During the meeting, sponsors should showcase their Phase 3 program, detailing the clinical trials they plan to conduct. The overarching question to have answered is: “If we conduct these trials and the data are positive, will this warrant submission and approval of our NDA?” Rather than asking open ended questions, sponsors should seek clear "Yes" or "No" answers from the FDA because Phase 3 trials are a major financial commitment, often costing tens to hundreds of millions of dollars. It’s crucial to ensure your plans align with FDA expectations and gain clarity on every aspect of the proposed trials.
Statistics show that first-cycle approval rates for products with EOP2 meetings are significantly higher than for those without. Addressing critical issues identified during the EOP2 meeting can prevent delays and rejections, highlighting the meeting's importance in the overall success of your drug development process.
The FDA evaluates several criteria during the EOP2 meeting, including:
While a successful EOP2 meeting doesn’t always equate to a successful and completed drug development, utilizing these meetings to their fullest potential is crucial—and sets you up for continued achievement in the future.
Engaging with regulatory experts can be hugely helpful in preparing for your EOP2 meeting. Bracken’s Regulatory Affairs team offers comprehensive support to navigate FDA interactions and optimize drug development strategies. Contact us today to ensure your program is on the right track for success.