Wednesday, January 15, 2014

Advisory Panel Vote: 10-1 In Favor -- Albeit A Pretty Narrow Indication -- For Zontivity® (Vorapaxar)

So it goes. It will still certainly never be a blockbuster -- and likely never cross the $400 million a year threshold. It may sell around $200 million a year, at peak -- if the full FDA approves it in about six weeks.

Here is the item:

. . . .Merck's experimental blood clot-preventing drug vorapaxar should be approved to reduce the risk of further heart problems in people who have suffered a recent heart attack, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.

The panel voted 10-1 in favor of the drug, which would, if approved, be sold under the brand name Zontivity. The FDA is not bound to follow the advice of its advisory panels but typically does so. The drug should not be recommended for patients who have previously had a stroke because of an increased risk of bleeding in the brain, the panel said. . . .

Now you know.


Anonymous said...

Condor, what's your take on the 'hidden' population of patients who may have had a mild, undiagnosed stroke? Do doctors not consider what's not in the health record or steer away from this pricey, branded choice?

Condor said...

Wow! Great question anon.!

Here in the US, it will be close to malpractice for a doctor to prescribe it -- if s/he has any reason to suspect prior (even mild) strokes, given the brain bleed issue.

So -- your point is well made.

It may fall short of $150 million at peak.

We shall see.


And, Namaste!

Anonymous said...

Thanks for your great coverage of all the Merck news this week. Very interesting and much appreciated!

Condor said...

Anon. -- My pleasure. Truly.

Just glad to know that someone finds it of value.

I'd do it anyway, but nice to know.

Thanks -- and Namaste!