Monday, 20 November, 2017

EMA for marketing authorization for 3 new medicines

11 Nov 2017, 01:09 ( 9 days ago)

DF-Xinhua Report
Photo Source EMA.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended marketing authorization for three new medicines in the European Union (EU).

EMA said in its press release that it recommended granting marketing authorisation for Ocrevus, Prevymis and Jorveza.

Ocrevus is for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS), while Prevymis is an antiviral medicine that prevents cytomegalovirus (CMV) reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic hematopoietic stem cell transplant. Jorveza is for the treatment of eosinophilic oesophagitis, a rare inflammatory condition of the esophagus.

Multiple sclerosis (MS) is a condition which affects the brain and/or spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. CMV is a common virus that usually causes only mild infections such as a sore throat. After infection, the virus remains in the body in a latent state. It can become active again and cause severe disease if the body's immunity is compromised.

Though several antiviral medicines are authorized in the EU for the treatment and prevention of CMV disease, due to the toxicities associated with these medicines, there is a need for better tolerated antiviral agents, said the EMA.

The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. 

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