You seem to be a bright fellow HDGabor... Thank you for your posts.
Bottomline the FDA is hesitant to approve another TG-lowering drug since several failed outcomes studies in recent years. And the FDA does not give weight to the positive sub-analyses within the HTG population.
The SPA essentially was out the window at ADCOM... The question placed to the panel was leading...
Amarin's strongest argument (other than the fact that Vascepa works) is that the FDA's argument that 'the science' has changed is flawed. The argument by the FDA (that rescinded the SPA) is vulnerable.
We know that Vascepa is about more than lowering TG's. Amarin is working (w/ studies) to show the FDA the MOA of Vascepa... this is important. Lot of moving parts here.
I am not surprised the appeal was rejected at the ODE-II LEVEL. My hope is Dr. Jenkins (New Drugs) and/or Dr. Woodcock (CDER Director) take a more wholistic and patient-centric view of Vascepa.
If you have thoughtful comments, best if you submit them to the Citizen Petition
Dr. Margaret A. Hamburg, FDA/OC Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Fax: (301) 847-3531 Email: margaret.hamburg@fda.hhs.gov
Dr. Janet Woodcock Director CDER 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Fax: (301) 847-8752 Email: janet.woodcock@fda.hhs.gov
Dr. John Jenkins Director, Office of New Drugs DHHS, FDA, CDER, OMPT, CDER, OND Building WO22, Room 6304 Silver Spring, MD 20993-0002 Phone: (301) 796-0700 Fax: (301) 796-9856 Email: john.jenkins@fda.hhs.gov
how did Lovaza get 14.2 on it label and how does Vascepa get it on its label? 14.2 shows treatment of high triglycerides significantly reducing triglycerides non-HDL-C and raising HDL-C
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