Sector News

New vaccine for Ebola among CHMP recommendations

June 2, 2020
Life sciences

Johnson and Johnson’s experimental two-stage vaccine for protection against Ebola virus disease is among eight medicines backed by the European Medicines Agency’s human medicines committee (CHMP) at its May meeting.

The vaccine, developed by J&J group Janssen, provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged one year and older.

It consists of two components, Zabdeno (Ad26.ZEBOV), which is given first, and Mvabea (MVA-BN-Filo), given around eight weeks later.

Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances ‘because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation’, the agency noted.

Elsewhere, the following medicines also took giant leap closer to EU approval:

  • MYR’s Hepcludex (bulevirtide), for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D;
  • Novartis’ Piqray (alpelisib)for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.
  • Roche’s Rozlytrek (entrectinib; conditional marketing authorisation), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer;
  • Nabriva Therapeutics Ireland’s Xenleta (lefamulin)for the treatment of community-acquired pneumonia in adults;
  • Accord Healthcare’s biosimilar Zercepac (trastuzumab)for the treatment of breast and gastric cancer; and
  • Accord’s generic Apixaban Accord (apixaban)for treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

By: Selina McKee

Source: Pharma Times

Join the discussion!

Your email address will not be published. Required fields are marked *

Related News

January 17, 2021

SII expects WHO emergency approval of Covid-19 vaccine soon

Life sciences

The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.

January 17, 2021

Sanofi to acquire clinical-stage biopharma firm Kymab for $1.45bn

Life sciences

According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.

January 17, 2021

Moderna poaches Amgen vet as CCO, jump-starting commercial team as it rolls out COVID-19 vaccine

Life sciences

Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.

Send this to a friend