When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk

The Challenge

Our client’s new drug met its primary endpoint in multiple Phase 3 trials but was still headed to a CHMP (Committee for Medicinal Products for Human Use) Oral Explanation meeting. The member countries were hung up on a bureaucratic interpretation of a regulation rather than looking at the big-picture clinical benefit. As we know, most companies go to an Oral Explanation because someone on the committee, generally the rapporteur or co-rapporteur, does not want the drug approved. Thus, we knew we had to overcome this procedural issue.

And we were in the midst of the COVID-19 pandemic, meaning that the meeting was completely remote, as were all of our presenters and responders. We had to submit our core presentation and any back-up slides that we thought we might use ahead of the meeting.

The Approach

In order to overcome these obstacles, we took a three-tiered approach. First, we challenged the CHMP’s interpretation of the regulation. We quoted both language from the regulations and CHMP minutes to convince the committee that our studies fulfilled the intent and criteria of the regulation.  Second, we focused the committee on the big picture, since the major objection omitted discussion of the impact and benefit to patients. We emphasized that the data demonstrated a clinical benefit over standard of care, with more rapid time to effect. We allocated enough time in our 20-minute presentation on the overall benefit/risk profile and tried to steer the committee away from technical interpretations to focus on patient outcomes that were omitted from the joint assessment report.

Importantly, we used the same technology platform and practiced in the exact environment that the meeting would be held. We left nothing to chance.

The Result

The CHMP adopted a positive opinion. Our client delivered a flawless presentation and effectively answered dozens of questions over the course of an hour. 

The Takeaway

Regardless of the committee’s objections, it is important to focus on benefit /risk. Regulations and p-values do not always tell the patient story. The applicant must address the major objections head-on but also bring the patient’s perspective to life for the committee. 

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