jueves, 9 de noviembre de 2017

FDA approves first drug for prophylaxis of cytomegalovirus infection and disease in bone marrow transplant patients - Drug Information Update

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

Today, FDA approved Prevymis (letermovir) tablets and injection, the first drug indicated to help prevent CMV (cytomegalovirus) infection and disease in adults who have been exposed to CMV and have received an allogeneic hematopoietic stem cell (bone marrow) transplant (HSCT). Among the more than 27,000 allogeneic HSCTs performed each year worldwide (including approximately 8,500 transplants in the United States), an estimated 65-80% of recipients have been previously exposed to CMV and are therefore at high risk for CMV infection. Without prophylactic measures, many patients undergoing allogeneic HSCT will experience CMV infection, which can cause a range of serious negative health outcomes in this population.  In a randomized controlled trial evaluating Prevymis as a preventive therapy in patients that had undergone an allogeneic HSCT, patients receiving Prevymis had a lower incidence of CMV infection than those receiving a placebo control.  
FDA granted this application Breakthrough Therapy and Orphan Drug designation, the latter of which provides incentives to assist and encourage the development of drugs for rare diseases. 
The most common Prevymis side effects include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness and stomach (abdominal) pain. Prevymis is contraindicated in patients receiving pimozide and ergot alkaloids and in patients receiving pitavastatin or simvastatin when co-administered with cyclosporine. 
For additional information, please visit Prevymis.

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