The U.S. Food and Drug Administration has given approval to a drug developed by pharmaceutical giant Merck & Co., Inc. (NYSE:MRK) to prevent the occurrence of infections in stem-cell transplant patients. An infection known as cytomegalovirus (CMV) is capable of causing major complications following stem cell transplants.
Despite the fact that antiviral treatments already exist, they have shortcomings which Merck has addressed with its drug, Prevymis (letermovir). The drug is to be taken once a day as a tablet but will also be available as an injection.
Lowers mortality rate
“Our findings demonstrate that letermovir is a significant and welcomed advance in the prevention of clinically significant CMV infection and lowers mortality in this highly vulnerable patient population,” Francisco Marty, Harvard Medical School’s associate professor and the lead author of the Merck study, said in an approval release.
Prevymis will be released to the market in December and will retail at $195 a tablet and $270 for the injection. Since the recommended dose is daily use for a period of 100 days following the stem cell transplant, each tablet course will cost $19,500 while the injection course will cost $27,000.
In the third phase of the clinical trial, it was observed that there was a significant reduction in the number of patients who developed cytomegalovirus. It was also observed that the number of those discontinuing treatment due to adverse effects was also significantly reduced. Bone marrow suppression in those who took Prevymis and those who took the placebo was at the same level.
The first treatment to be developed to prevent the cytomegalovirus infection was Ganciclovir but while it reduces the risk of the infection, it leads to a low count of white blood cells in about 30% of the patients consequently causing the risk of fungal and bacterial infections to rise.
The approval of Prevymis will come as good news to Merck after suffering some setbacks in the last few weeks. This includes its decision to pull a filing in Europe for Keytruda, a cancer immunotherapy, thus preventing the use of the drug in a wider base of patients.
On Thursday shares of Merck & Co Inc edged downwards by 0.65% to close the day at $56.21.