Amarin Corp Plc (AMRN)

[HDGabor]

JL,

What do you think about the following? Two notes to the below. I had the view, FDA has only a limited right to rescind the SPA (it should be based on a valid / good reason) but has the right, so the question they exercised their right correctly or not. I am not a physician I don’t know / could not evaluate the science.

“the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug” – I read it as the director determines that the available scientific issues are not enough due to reevaluation and improved understanding of the relevant scientific knowledge (w or w/o new substantial scientific issue arose) since the ANCHOR trial began.

I do not know (we do not have exact information) that “FDA concluded that in its view the totality of scientific data and information” includes or not the new data and information became available after the SPA rescission as acc. to the Formal Dispute Resolution “Because all FDA decisions on any dispute must be based on information already in the relevant administrative file (§ 10.75(d)), no new information should be submitted as part of a request for reconsideration or appeal. If the sponsor has new information that may affect the original decision, any appeal should be deferred until the new information has been submitted to the administrative file and reviewed by the division.”

Theravance’s case (Vibativ) is not exactly the same, however it looks like similar: Fair is Fair; But Science is Science

Because some bureaucrats get together and decide they don't believe in lab tests anymore is not a new scientific issue casting doubt of Vascepa's efficacy

According to the Guidance for Industry / Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998), “When the pathophysiology of a disease and the mechanism of action of a therapy are very well understood, it may be possible to link specific pharmacologic effects to a strong likelihood of clinical effectiveness. A pharmacologic effect that is accepted as a validated surrogate endpoint can support ordinary approval (e.g., blood pressure effects, cholesterol-lowering effects) and a pharmacologic effect that is considered reasonably likely to predict clinical benefit can support accelerated approval under the conditions described in 21 CFR 314 Subpart H and 21 CFR 601 Subpart E”

Furthermore, they could refer to two AdCom to support their new assumption:

Oct 16: Meanwhile FDA did not address their real question directly / clearly to the AdCom “…described lipid/lipoprotein parameters are sufficient to grant approval … prior to the completion of REDUCE-IT?, Dr. Hiatt made it clear “the issue on the table today is whether we should approve something as a surrogate endpoint.” The answer was no and two weeks later the SPA was rescinded.

2011 ACCORD-Lipid (Oct 16 FDA BD, page 82 of 94): “However, several members recommended that the FDA consider requiring a different level of evidence for future lipid altering drugs, transitioning away from surrogate endpoints to relevant clinical cardiovascular outcomes especially for indications for add-on therapy to statins.”

However, FDA did not notified Amarin about this issue within a reasonable period of time after they become aware of it.

Thanks,
HD