logo
Plus   Neg
Share
Email

Merck Gets FDA Approval Of Prevymis For Prevention Of CMV Infection

Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, said that the U.S. Food and Drug Administration has approved Prevymis or letermovir once-daily tablets for oral use and injection for intravenous infusion.

Prevymis is indicated for prophylaxis or prevention of cytomegalovirus or CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).

CMV is a common and potentially serious viral infection in allogeneic HSCT recipients. CMV-seropositive patients who undergo an HSCT are at high risk for CMV reactivation. Any level of CMV infection is associated with increased mortality in HSCT patients.

In the pivotal Phase 3 clinical trial supporting approval, significantly fewer patients in the Prevymis group, or 38 percent, compared to the placebo group or 61 percent, developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-HSCT, the primary efficacy endpoint.

Prevymis is expected to be available in December. The list price per day for Prevymis tablets is $195.00 and for Prevymis injection is $270.00. Wholesaler acquisition costs do not include discounts that may be paid on the product.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Malaysia has filed criminal charges against Goldman Sachs and two of the bank's former employees in connection with a corruption and money laundering probe tied to that country's sovereign wealth fund, 1 Malaysia Development Bhd, or 1MDB. Shares of Goldman Sachs are losing more than 2 percent in regular trading on the New York Stock Exchange. Alphabet Inc.'s Google said Monday that it will expand its presence in New York City by investing over $1 billion in capital requirements to establish a new campus known as Google Hudson Square. Google noted that its investment in New York is a huge part of its commitment to grow and invest in U.S. facilities, offices and jobs. Blockchain and artificial intelligence are the fastest-growing job categories, according to a report published by LinkedIn, the networking platform for professionals. Blockchain Developer is topping the list amid the ongoing hype around blockchain and cryptocurrency. As per the Emerging Jobs Report for 2018, the U.S has seen a surge in demand for people with blockchain development skills.
Follow RTT