news

EC approves ustekinumab to treat plaque psoriasis in patients age six to 11

4
SHARES

The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.

Young girl with red irritated arm

An application for the expanded use of Stelara® (ustekinumab) for the treatment of paediatric patients ages six to 11 with moderate to severe plaque psoriasis has been approved by the European Commission (EC).

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

The marketing authorisation for ustekinumab follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), issued on 12 December 2019.

Ustekinumab has been previously approved for use in adolescent and adult patients with plaque psoriasis, aged 12 years and older, and is now the first available biologic treatment in this patient population to selectively address the IL 23/IL 12 pathway. In addition to psoriasis, ustekinumab has also been approved for the treatment of three further immune-mediated conditions in the EU: psoriatic arthritis, Crohn’s disease (CD) and ulcerative colitis (UC).

Janssen, which produces the drug, conducted the multicentre, open label, randomised, double-blind Phase III trial which found ustekinumab improved the signs and symptoms of plaque psoriasis, as well as health‑related quality of life in paediatric patients aged six to 11 years old. In general, the quality and safety data reported up to one year in the paediatric patient study was similar to those seen in studies in adults with plaque psoriasis.

“This latest EC approval is a significant milestone for young children struggling to cope with the symptoms of psoriasis,” said Lloyd Miller, Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC. “We’re delighted that this therapy, which has a well-established safety and efficacy profile in adults with plaque psoriasis and other immune diseases, is now expanded to children as young as six who are living with this chronic disease.”

Share via
Share via