We've Been Following The Letermovir Story Since At Least Mid-2012... Now FDA Priority Review In Kidney Transplant Settings...

This is very good news, for the franchise whose chemical name is Letermovir, has long since been branded (at Merck) as Prevymis^®. The then candidate (then called AIC-246) was acquired from AICuris in 2012 (just two of my backgrounders may be found under those links here -- and search in the box above for "letermovir" -- for much more).

And this continues the likely ramp for the anti-viral, with new indications. . . arriving year after year. Here's the latest, on a "closed markets" Monday -- for Presidents' Day:

. . .Merck announced that the FDA has accepted and granted priority review to a supplemental new drug application (sNDA) seeking expanded use of its antiviral medicine, Prevymis. The sNDA seeks approval for Prevymis for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. The FDA is expected to give its decision on the sNDA on Jun 5, 2023.

Prevymis is presently approved for the prevention of clinically-significant CMV infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). . . .

The FDA also accepted another sNDA to allow the extended use of Prevymis from 100 days to 200 days in adults receiving an HSCT who are at risk of late CMV infection. The decision on this sNDA is expected on Sep 7, 2023. . . .

Now you know -- out, grinning. Has it been 11 years, already. . . since that October trip in 2012 -- and my first post on it? Wow.

नमस्ते