Wednesday, October 18, 2023

Merck Wins EU Longer Duration Therapy Approval For Novel Cytomegalovirus Antiviral Agent... Good News.


Cytomegalovirus may often be the scourge of immuno-compromised patients. [2016 era backgrounder of mine, here -- during Cubbie fever. Smile.]

And that is doubly true for patients who are recovering from a transplant, as most of them will have been given a regimen to suppress their immune responses -- to decrease the odds of an organ rejection. [Here is a February 2023 backgrounder of mine, as well.] So it is, that now the EU authorities have green-lit use of a Merck therapy -- for a 200 day duration. The prior approval only was for 100 days. Yes, this is good news:

. . .[Merck] said on Tuesday the European Union medicines regulator recommended a marketing authorisation for the company's drug Prevymis to treat a type of infection in adult kidney transplant recipients at high risk.

The drugmaker says Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) also recommended the approval for extending dosing of the drug to 200 days from 100 days, following a type of transplant in adult patients. . . .

Prevymis is an antiviral agent that was initially approved by the U.S. Food and Drug Administration (FDA) in 2017 and by the EMA in 2018 for prevention of a type of viral infection called Cytomegalovirus (CMV) in some patients who have received a type of stem-cell transplantation. . . .


So, the freight train keeps on rolling out of Rahway. And with all this high margin drug revenue. . . one may fairly ask: why is it, exactly, that Mr. Rob Davis won't willingly sit down and negotiate with his largest customer, on some drugs now over 20 years on market -- that do save lives, but upon which Merck has already banked profits deep into the billions of dollars? Why. . . indeed?

And yes, the lesson of Lehman here applies.

नमस्ते

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