Replies to post #85639 on Biotech Values

[iwfal]

CRME's drug is for something of a niche indication compared with the wide usage that amiodarone has despite its absolutely miserable side effect profile.

Why? Am I missing something in efficacy? Or in SAE? On both median time to AF recurrence (which is probably the most common metric for anti-rhythm drugs) and SAE the ph iib results look clearly competitive or superior to Amiodarone.

In it's oral formulation it improves median time to recurrence of AF from 27 days to 90 days - which, at a factor of 3, is competitive with Amiodarone.

And for the ph iib PR the treatment group was reported to have no excess SAE over placebo - which is better than Amiodarone would do (with on the order of 10% having either liver elevation or thyroid issues)

Nota bene - the median performance isn't as good as it sounded (==> HR=1/3) when I looked more at the data since they also report the 90 day recurrence rate and the placebo arm essentially stops recurring after the median (the median may have been at 27 days but by 90 days only 37% have recurred). Implying an HR closer to 0.67 (assuming exponential curves, which clearly these are not) But note that off hand I don't know whether the Amiodarone curves do the same plateau. Based upon memory there is some indication that they do.

PS I appreciate any different look at the data you can provide.

[genisi]

CRME
On vernakalant(i.v): There's a head-to-head phase III trial in Europe of vernakalant vs amiodarone for acute AF conversion. (http://clinicaltrials.gov/ct2/show/NCT00668759?term=AVRO&rank=1)
If vernakalant shows superior efficacy with adequate safety (I think it will), it will become the drug of choice for conversion of AF, and the European label might include HF patients.
Oral vernakalant likely will be safer but less effective than amiodarone, but will be interesting how it will compare to Multaq.