Merck seeks more approvals for infectious disease drug

Pharma giant Merck is looking to bag more indications for its cytomegalovirus (CMV) treatment Prevymis.

The pharma announced on Friday that the FDA has accepted two NDAs for the drug, also known as letermovir. Merck is hoping to grab another indication to be used in the prevention of CMV disease in adults who receive kidney transplants. The FDA has set the PDUFA date for June 5.

A second NDA has also been put forward to extend the use of Prevymis from 100 to 200 days in adults who receive a bone marrow stem cell transplant and who are at risk for CMV infection. The PDUFA date is set for Sept. 7.

For the kidney transplant indication, Merck will be using the data from a Phase III trial last year that compared Prevymis to valganciclovir, or Valcyte, which treats CMV for kidney or heart transplants. The results showed that Prevymis had a better safety profile than Valcyte and fewer adverse events. Instances of white blood cell reduction were 38% lower in the Prevymis group than for Valcyte, earning Merck’s drug a p-value of p<0.0001.

Nicholas Kartsonis

“Certain high-risk individuals who develop CMV infection following receipt of a kidney transplant are at increased risk for transplant failure and death,” Nicholas Kartsonis, a senior VP in Merck Research Laboratories’ infectious diseases department, said in a release.

The data for after a bone marrow transplant are also backed by a Phase III trial studying disease prevention at 200 days against a placebo. Merck stated in its release the trial hit its primary endpoint, with the drug reducing CMV infection from week 14 through week 28 after the transplant. The full data will be presented at a medical conference Saturday.

Prevymis came onto the scene in 2017, earning the FDA’s OK to treat CMV after bone marrow stem cell transplant — which, so far, is its only approved indication. Merck picked up the drug in a $500 million-plus deal with AiCuris, which netted the biotech a $122 million milestone payment.

The drug, according to Merck’s results from last year, brought in $428 million in sales.

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