Merck's Antiviral Drug Prevymis Gains NICE Approval in England for CMV Prevention in HSCT Patients

Recently, inMerck & Co., Inc.After agreeing to a confidential discount, the UKNICEApprovedPrevymisForHematopoietic Stem Cell Transplantation（HSCT）Patients, to prevent the reactivation of cytomegalovirus in their bodies.

Last year, Merck’s Prevymis was rejected by UK regulators. NICE initially voted against the drug’s application, citing concerns about its price and its ability to help patients extend their lifespan. Although Prevymis did demonstrate potential in preventing cytomegalovirus reactivation, reviewers noted that the drug had limited efficacy in reducing mortality among patients with viral reactivation compared with placebo.

According to the company, approximately50％To80％In the UK, adults are infected with cytomegalovirus (CMV), a member of the herpesvirus family. In infected individuals, the virus often remains latent and does not cause any clinical symptoms. However, due to impaired immune systems in patients, CMV reactivates in approximately 50% of those undergoing stem cell transplantation.

Individuals with normal immune function rarely develop cytomegalovirus (CMV) symptoms after primary infection; the virus typically remains inactive or latent in the body for life. Immunosuppression may allow the virus to reactivate, leading to symptomatic disease or secondary infections caused by other pathogens. CMV-seropositive patients undergoing hematopoietic stem cell transplantation (HSCT) are at high risk for CMV reactivation, which can result in end-organ damage, including gastrointestinal disease, pneumonia, or retinitis, thereby increasing the risk of graft failure and mortality.

Prevymis is a once-daily oral tablet or intravenous therapy. Prevymis is a novel non-nucleoside cytomegalovirus inhibitor (3,4-dihydroquinazoline) that inhibits viral replication by specifically targeting the viral terminase complex. It is unlikely to exhibit cross-resistance with drugs of other classes. Prevymis is fully active against cytomegalovirus populations resistant to DNA polymerase inhibitors, while DNA polymerase inhibitors remain active against Prevymis-resistant viral populations.

Currently, Merck & Co. has not released a report on the sales performance of Prevymis. Merck has priced the drug for its injectable formulation.($270 per day)and the oral version($195 per day), with a treatment course of 100 days, the cost of therapy for this drug will amount to as high as$27,000or$19,500. Merck & Co. estimates that the drug's sales in 2020 could reach approximately$370 million, accounting for approximately 1% of the company's annual pharmaceutical revenue.

Prevymis was approved in November 2018U.S. FDAApproved and officially launched in the United States at the end of last year. The approval of Prevymis was based on positive data from a pivotal Phase III clinical study. The study results showed that the incidence of cytomegalovirus infection was significantly lower in the Prevymis treatment group (38%) compared to the placebo group (61%), meeting the primary endpoint of the study.As the first approved cytomegalovirus therapy in 15 years, Prevymis offers a glimmer of hope for Merck’s struggling virology business.

Two Other Antiviral Drugs from Merck & Co., Including an HIV MedicationIsentressand Hepatitis C Treatment DrugsZepatierSales declined across the board last year. Amid a shrinking patient population and intensifying competition, global sales of Zepatier plummeted to $455 million in 2018, representing a steep 73% drop from the $1.7 billion recorded in 2017. External analysts believe that Zepatier’s sales are unlikely to rebound soon, and Merck & Co. also anticipates further declines in revenue for the drug. In the first quarter of 2019, Zepatier’s sales amounted to only $114 million, falling short of the $131 million reported during the same period in 2017.(Compiled by Sina Medicine/Fan Dongdong）

References:

1、Merck antiviral drug Prevymis wins over England's reluctant cost watchdogs

2、NICE backs Merck & Co's Prevymis for CMV