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biotech jim

03/21/15 1:13 PM

#188883 RE: biomaven0 #188882

Amiodarone results in pulmonary fibrosis for those who take the drug chronically. I know, as that is the nasty side effect that my mother had from amiodarone. Her cause of death a few months back was pulmonary fibrosis. Dronedarone (marketed as Multaq) was the Sanofi follow on to its amiodarone and is quite similar in structure, has substantial side effects (QT prolongation, bradycardia, nausea, diarrhea, rash, and creatinine elevation) and the efficacy is weak compared to amiodarone. Both drugs are considered multiple ion channel blockers.

Here are the updated labels for both Sovaldi and Harvoni, and it is stated that the mechanisms for DDI with amiodarone for both is unknown.

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

We need a good drug for Afib. I agree, Peter, that there likely is not a significant overlap of amiodarone users with the treated HCV population.
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dewophile

03/21/15 1:40 PM

#188885 RE: biomaven0 #188882

Thx Peter

Likely not a significant overlap with the treated HCV population



This may be true in the US given the peak age incidence of HCV here is 50-70, although conditions like afib in the older end of this age range is not trivial. If Harvoni is stigmatized by these reports in pts w arrhythmias it could be meaningful - even 2-3% loss of share in such a large market is real money. viekira does have precautions in its label w amiodarone as well but i would think it would be preferred for a pt on amiodarone or who is at high risk of needing it given this recent FDA warning and drug-related pt death
i woudl also add that in japan average age is older and this could have a more significant impact commercially when abbv/gild compete in this market