Wednesday, April 8, 2015

Kenilworth Adds Genotype 4 To Its Combo Breakthrough Designation At FDA: Smallish Good News

UPDATED @ 2 PM EDT | Tracy Staton at FiercePharma has some smart analysis of how, and when, all of this might play out. I still think Gilead is in the driver's seat -- and she does too. But do go read hers, here. [End, updated portion.]

Back in October 2013, Merck received an FDA breakthrough designation on the combo pill -- for certain genotype 1 Hep C patients. That was withdrawn by FDA in January 2015, due to AbbVie's (Abbott spinoff's) success, out in the field. Today Merck reports it has been re-granted that coveted status, related to a more narrow subset -- end-stage renal patients with genotype 1, as well as (for the newly added) genotype 4 patients -- of all classes.

This is good news, and Merck is likely to present pretty strong (90% plus response rates) at the International Liver Congress meeting later this month. Here is a bit of The Wall Street Journal, on it all:

. . . .Merck said Wednesday that its hepatitis C drugs have been designated breakthrough therapies by the U.S. Food and Drug Administration.

The news comes three months after the agency said it would rescind breakthrough designation due to the introduction of competing treatments for the liver disease. The drugs, grazoprevir and elbasvir, cured at least 90% of infected patients in a mid-stage clinical trials and Merck is testing them in late-stage studies. It hopes to file an application to market a new two-drug, single-pill combination. . . .

We will -- as ever -- keep an eye on this, but with FDA having granted BMS's Opdivo essentially a "next day" approval, after data submission on a breakthrough status, coupled to priority review -- it seems there is a new order underway at FDA. So, it is not impossible that Merck might get a late June 2015 approval, after filing the data from the liver meeting, should it too win a priority review from FDA. We shall see.

Housekeeping Note: We will be off grid for the balance of the week, through to next Monday -- unless something major breaks, inside Kenilworth. So, do be excellent to one another.

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