FDA OKs Merck Drug that Prevents Infection Post-Stem Cell Transplant

11/09/17

By Reuters Staff

(Reuters) - Merck & Co Ltd’s drug to prevent serious infection in patients who undergo a type of stem cell transplant was approved by the U.S. Food and Drug Administration, the drugmaker said on Thursday.

Merck said the drug, which is expected to be available from December, was approved both as a tablet and an injection. The list price for the tablets is $195 per day, while it is $270 a day for the injection.

The recommended dosing for the drug is once everyday for 100 days after the stem cell transplant, bringing the effective list price to $19,500 for the tablets and $27,000 for the injections.

The list price of a drug is not necessarily what patients actually pay. “Out-of-pocket” costs vary based on the duration of the treatment and individual healthcare plans.

Merck’s drug, Prevymis, was approved to prevent cytomegalovirus (CMV) infection - a complication associated with bone marrow transplants that treat acute leukemias, other cancers and diseases of the bone marrow.

CMV can occur in patients who have undergone a transplant of hematopoietic stem cells, which are located in the bone marrow and derived from a donor.

While there are other drugs that treat CMV once it occurs, attempts to find a safe drug that can prevent it had failed.

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