Merck & Co., Inc. (MRK - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing approval of Prevymis (letermovir).
Merck is looking to get Prevymis approved in the EU for the prevention of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). Merck expects a decision from the European Commission within two months.
We remind investors that only last week, Prevymis received approval from the FDA for the prevention of CMV infection. A common and potentially serious viral infection in allogeneic HSCT recipients, CMV infection is associated with increased mortality in HSCT patients.
Merck said that Prevymis is the first new CMV medicine to be approved in the United States in 15 years. Merck intends to launch the drug in the United States next month at a list price of $195 per day for the tablets and $270 for the injection.
Merck’s shares have declined 6.4% this year against a 14.5% increase for the industry.
Some other key pipeline candidates of Merck include doravirine for HIV with a new drug application (NDA) filing expected before the end of the year, and MK-7264, which is being developed in phase II studies for refractory, chronic cough and idiopathic pulmonary fibrosis (IPF) with cough.
Merck and Pfizer (PFE - Free Report) have developed diabetes candidate ertugliflozin for which regulatory applications are under review in the United States and the EU. The companies have filed three separate NDAs for ertugliflozin, one for monotherapy and twoforfixed-dose combinations with metformin and with Januvia/sitagliptin, respectively. A decision from the FDA is expected next month.
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the industry are Johnson & Johnson (JNJ - Free Report) and Ligand Pharmaceuticals Incorporated (LGND - Free Report) , both with a Zacks Rank #2 (Buy).
Shares of J&J are up 21.3% while earnings estimates for 2018 have gone up by 1.2% over the past 30 days.
Shares of Ligand Pharmaceuticals have risen 40.5% this year so far while earnings estimates for 2018 have increased 0.5% in the past 60 days.
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