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Excerpt of letter sent to CDER Medical Policy Council
This is part of a letter sent today to the CDER Medical Policy Council members (which include Drs. John Jenkins and Janet Woodcock).
Can
FDA sustain its burden to prove, using sound scientific evidence, that it is now
unlikely (or just less likely than it was at the time of the SPA) that
administration of Vascepa to the ANCHOR population would confer a clinical
benefit? The answer is “No,” FDA cannot.
It
remains unproven whether administering Vascepa to the ANCHOR population would either
confer or not confer a clinical benefit (only REDUCE-IT will provide conclusive
proof of whether there is clinical benefit).Subsequent to the SPA agreement’s having been entered into, however,
there has been published significant, relatively new, evidence of elevated
triglycerides’likely causal role in
CVD, suggesting that Vascepa’s (uncontroverted) lipid and other effects (e.g.,
lowering high triglycerides (HTG), lowering ApoC-III, and reducing systemic inflammation,
among others) may reduce atherogenesis and/or otherwise reduce CVD risk.
As
was just published by two key opinion leaders in the Lancet, “The evidence that
raised concentrations of remnant cholesterol, marked by raised triglycerides,
are an additional causal risk factor for cardiovascular disease and all-cause
mortality, is increasing.”Lancet 2014; 384, 626-635, at 633.(emphasis added)
That
evidence, when viewed objectively, and contrary to the rescission’s underlying
rationale, increasingly supports the suggestion that the HTG-lowering drug
at issue, especially one that also lowers ApoC-III and that reduces systemic
inflammation, without raising LDL-C, would confer clinical benefit, more
so than did the totality of the evidence at the time the SPA was
entered into.Clinical benefit is now
incrementally more, not less, likely.
Accordingly,
the rescission is unsustainable on its merits, and the SPA should (and must) be
reinstated.
Should
FDA honor its SPA agreement, upon which industry has relied in conducting an
expensive clinical trial, the design and endpoints of which FDA approved, and
which endpoints were met?The
answer is “Yes,” FDA should, where there is increasing scientific evidence suggesting
elevated triglycerides’ having a causal role in CVD such that the underlying
premise of potential clinical benefit remains at least reasonably possible (if
not likely) and, by universal agreement, worthy of significant effort/expense
to study in an outcome trial.Reinstatement is
simply the “right thing to do” because of the scientific merits.Moreover, the entire pharmaceutical industry,
well aware of the science, is watching this matter closely, asking whether the
FDA will honor its agreements, will recognize when the totality of the evidence
shows that a decision to rescind is no longer valid, and will take corrective
action. As well, the American people,
and Congress, are interested to know whether FDA will adopt clear and
appropriate procedures by which SPAs will be administered, their rescission (and
any appeal therefrom) decided upon, following administrative due process, and
based upon, to the extent possible, analogous principles of contract law.Under the facts of this case, only one disposition,
reinstatement, can be justified.
Would
patients benefit were the SPA to be reinstated?The
answer is “Yes,” patients would benefit because reinstatement would likely lead
to sNDA approval, so that those mixed dyslipidemia patients who may then choose
to receive Vascepa would experience significant improvement of most lipid
markers, reduction of systemic inflammation, and (at least) a reasonable chance
that the drug will lower their risk of developing or progressing CVD, with
negligible risk.More broadly,
ANCHOR approval would remove the significant jeopardy (caused by ANCHOR SPA
rescission) to completion of the REDUCE-IT trial.The global medical community desperately
needs conclusive evidence whether recent (multiple –sourced) evidence
suggesting a causal relationship between elevated triglycerides and CVD is
indeed a reflection of an actual, causal relationship and whether medical
lowering of HTG in turn decreases that risk.The REDUCE-IT trial would do just that, but only if it can be completed
as planned.Millions of patients would
benefit from that knowledge, if FDA upholds its end of an agreement it reached
with the sponsor when ANCHOR was planned and designed.