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FDA advisory panel discusses future research for novel drug in setting of CABG
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A thromboxane receptor antagonist, PRT061103, was the impetus for a non-voting discussion featuring the Cardiovascular and Renal Drugs Advisory Committee.
The meeting convened at the request of the sponsor, Portola Pharmaceuticals, which posed questions to the committee regarding the appropriate clinical study design for its PRT061103, a drug intended for prevention of CV events in patients with aspirin intolerance caused by immunologically based adverse reactions, particularly in the setting of CABG.
After presentations by the sponsor, committee members took questions on the effectiveness of aspirin in CABG to help clarify the potential use of PRT061103 in this setting. Although they unanimously supported the statement that aspirin is the standard of care in perioperative and postoperative treatment of a general population undergoing CABG, they said aspirin is not compelling or persuasive in preventing bypass graft failure, despite there being an indication of efficacy.
When questioned whether demonstration of an effect on bypass graft failure could serve as an approvable endpoint for a broad population of CABG in a future trial, the response among committee members was overwhelmingly no.
“This is a completely inappropriate endpoint from the aspect of why we are doing the CABG and what we are trying to get for the patient,” said Scott Emerson, MD, PhD, professor of biostatistics, University of Washington, Seattle. “There can come a time when something has no impact on the CV survival endpoint that we want but does have an impact on quality of life. … [However], I don’t think this pertains here.”
From a clinical viewpoint, Henry R. Black, MD, clinical professor of internal medicine, New York University School of Medicine, said there are two critical pieces of missing data. “One is: How much the effect size was? No one is happy with what aspirin did, and what kind of effect size would persuade you that this was a reasonable alternative regardless of whether they were aspirin intolerant or not?” he said. “The other thing we don’t seem to know and have to ask about is what other effects this might have. We don’t have the data to answer these things.”
The afternoon session was closed to the public to protect proprietary information of the sponsor. – by Brian Ellis
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