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Merck's New Antiviral Drug "Litemovir Injection" Approved for Marketing in China

ECHEMI 2022-05-13

Today, the official website of China's National Medical Products Administration (NMPA) announced that Merck's (MSD) new antiviral drug letermovir injection has been approved for marketing. It is worth mentioning that the tablet dosage form of the drug was approved in China in January this year for the preventive treatment of cytomegalovirus.


Cytomegalovirus (CMV), a widespread herpes virus, poses a serious threat to the life and health of patients with hematopoietic stem cell transplantation (HSCT). Studies have shown that among these patients, the seropositivity rate of cytomegalovirus can be as high as 92%, and the virus resurgence rate can be as high as 30-80%. According to an earlier press release from Merck, prior to the introduction of Letermovir, there was no drug approved globally for the prevention of CMV infection after allogeneic HSCT. Although preemptive treatment is an effective method to control CMV, there are still many allogeneic HSCT recipients with refractory cytomegalovirus infection problems, and preemptive treatment drugs have adverse reactions such as bone marrow suppression and nephrotoxicity, which increase the death of patients risk and medical burden.


Letermovir is a novel non-nucleoside CMV inhibitor (3,4-dihydroquinazoline). Public information shows that the product has a new anti-CMV effect, by inhibiting the activity of the cytomegalovirus terminal enzyme complex, preventing the processing and packaging of viral DNA, thereby exerting an anti-viral effect. The difference from DNA polymerase inhibitors is that letermovir is more selective for CMV, and the intensity of action is also significantly improved.


In November 2020, Letermovir submitted and accepted four new drug marketing applications in China, including injection and tablet formulations. In January 2022, the tablet formulation of Letermovir was approved in China (trade name Premin) for the prevention of cytomegalovirus infection in adult recipients of cytomegalovirus seropositive [R+] undergoing allogeneic hematopoietic stem cell transplantation and cytomegalovirus disease. In the United States, letermovir was approved by the FDA in November 2017 as an oral tablet and an intravenous solution for the prevention of CMV infection and related diseases in adult patients who are CMV seropositive after allogeneic HSCT.


According to a previous Merck press release, in the pivotal Phase 3 clinical trial supporting the FDA approval of Letermovir, letermovir (38%, n = 122/325) clinically significant CMV infection, treatment discontinuation, or a significant reduction in missing data at 24 weeks after HSCT, meeting the primary efficacy endpoint. At 24 weeks post-transplant, all-cause mortality was 12% and 17% for letermovir-treated patients compared with placebo. In addition, the incidence of myelosuppression in the letermovir group was comparable to that in the placebo group. The median time to transplant was 19 days in the letermovir group and 18 days in the placebo group.

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