EMA Highlights: Green light for new medicines

by Gary Finnegan – The EMA’s influential Committee for Medicinal Products for Human Use (CHMP) approved six new medicines at its June meeting, including a breakthrough hepatitis C drug.

The committee recommended granting a marketing authorisation for Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.

This is a significant move and could be the first of a number of new treatments for HCV. Several new classes of direct-acting antivirals are under development and further marketing licenses are anticipated.

Daklinza, which is the first representative of a new class of antivirals that block the action of NS5A, is a protein which is essential for HCV to replicate.

Until very recently, the standard of care for hepatitis C included a combination of the medicines pegylated interferon and ribavirin, with or without an inhibitor of the viral NS3/4A protease enzyme.

However, in a note released by the EMA, it said interferon-based therapies are associated with potentially serious side effects, which are sometimes difficult to manage. “One of the major benefits of the new antivirals is to provide an interferon-free treatment option for HCV infection,” it said.

HCV infection is a major European public-health challenge. It occurs in between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common single cause of liver transplantation in the EU.

There remains a public-health need to make such new treatment options available for patients where available interferon-free treatment regimens may have suboptimal effectiveness, according to the regulator.

The other drugs approved this month are:

–          Abasria (insulin glargine) for the treatment of diabetes mellitus. Abasria is the first biosimilar insulin to be recommended for marketing authorisation in the European Union.

–          Vizamyl (flutemetamol (¹⁸F)) for the visual detection of amyloid-beta neuritic plaques in the brain.

–          Triumeq (abacavir sulfate / dolutegravir sodium / lamivudine) for the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg.

–          Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) for the control of serum phosphorus levels in patients with end-stage renal disease.

–          Clopidogrel / Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid) for the prevention of atherothrombotic events.

In addition, the CHMP recommended that marketing authorisation by granted for the hybrid medicine Vantobra (tobramycin). This was adopted via written procedure in on 2 June 2014 ahead of the meeting in late June.

Extensions of indications were agreed for Avastin, Eliquis, Enbrel, Eylea, Isentress, Kalydeco and Stivarga. These must all be formally approved by the European Commission.