Friday, December 18, 2015

Merck's Elbasvir/Grazoprevir Hep C Next-Gen Combo Dropped Back to "Regular Review," In The EU: Now Mid 2016 Decision

While the doublet still remains on the FDA's calendar for an action/decision in mid-January of 2016, the analagous EU authorities have taken it off the fast track there, and so Merck announced early this morning that it would not expect an EU decision -- until mid 2016. It would thus seem even clearer -- given the November 2015 report, on Gilead's ASTRAL data -- that this Kenilworth duo may only ever run as a second to Gilead's next gen offering, and may even run third, to Abbvie's oncoming combo. [Earlier backgrounder, here -- from July of 2015.]

And so -- it is only minor news, I think, that the EU will place the combo candidate back on "regular track" -- and thus should not create any sort of a lasting dent in Merck's NYSE price:

. . . .[Merck (or MSD outside the US)] announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has responded to the company’s marketing authorization application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C (HCV) infection. The CHMP advised Merck that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. Under the revised timeline, Merck anticipates a European Commission decision in mid-2016. . . .

Keniworth may get some additional news from FDA on first line melanoma for pembrolizumab -- either tonight after market close, or on Monday (if FDA adheres to its calendar). We shall see. An exciting holiday fun filled weekend awaits, including singing the Messiah, as ever. . . be excellent to one another!


Anonymous said...

Merck DID indeed receive first line approval for Keytruda in melanoma in US. It also looks like reimbursement for Opdivo in Europe without a biomarker in NSCLC is going to be an uphill battle. Who knows - Merck's strategy may pay off after all - at least in Europe. Selecting patients who may truly benefit from anti-PD-1 therapy is the right thing to do.

Condor said...

Indeed. Now we wait to see whether BMS's Opdivo lead is trimmed by Kenilworth, in 2016.

Namaste -- and a hpapy New Year!