News

Stelara: FDA and  EMA to ballot
Enlarge image

RegulatoryEUNetherlands

Stelara: FDA and EMA to ballot

10.12.2012 - J&J subsidiary Janssen pushes its antibody Stelara for approval against psoriatic arthritis. FDA and EMA will decide over the filed application.

The Johnson & Johnson subsidiaries Janssen Research & Development, LLC, and Janssen Biotech, Inc, from Horsham (USA) as well as Janssen Biologics B.V. from Leiden (The Netherlands) announced on 6 December the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA), respectively. In both cases, the companies ask for the approval of Stelara (ustekinumab) for the treatment of adult patients with active psoriatic arthritis, a type of inflammatory arthritis that affects up to 30% of people suffering from psoriasis. Stelara is a human interleukin (IL)-12 and IL-23 antagonist, that is currently approved in 69 countries for the treatment of moderate to severe plaque psoriasis. After promising multicentre, randomised, double-blind, placebo-controlled Phase III trials (PSUMMIT I and II), J & J now hopes to expand the indication range for Stelara.

Jerome A. Boscia, Vice President at Janssen Research & Development, said: "The efficacy and safety of Stelara have been shown in a large Phase III clinical development programme for the treatment of active psoriatic arthritis, a disease for which tumour necrosis factor inhibitors are currently the only approved biologic therapies, and additional therapeutic options are needed." The trials included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dl in spite of previous treatment with conventional therapy. Patients with previous exposure to tumour necrosis factor (TNF) inhibitors were also partially included. Stelara is also in a Phase III development for the treatment of moderately to severely active Crohn's disease.

Some weeks ago Janssen Biotech demonstrated its dedication to R&D by announcing collaborations with Danish Genmab A/S on the production of bi-specific antibodies as well as the development of daratumumab, a CD38 antibody.

© eurobiotechnews.eu/ml

http://www.european-biotechnology-news.com/news/news/2012-04/stelara-fda-and-ema-to-ballot.html

R&DEUBelgium

18.12.2014 IMI has launched a €115m call for proposals involving a project in collaboration with the Bill and Melinda Gates Foundation to improve vaccines against whopping cough in children.

PoliticsEUPolandItalySpainUK

16.12.2014 Two consortia combined of 144 European companies, research institutes and universities have been selected for funding by the EIT in the areas of health and raw materials. Both clusters are set to acquire €1.1bn over the next seven years.

M&ALuxembourg

11.12.2014 Luxembourg bio-analytical testing company Eurofins Scientific has signed an agreement to acquire Boston Heart Diagnostics Corp. for an initial €112m.

StudySwitzerlandEU

10.12.2014 When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.

FinancingUKSpain

09.12.2014 British drug delivery specialist Midatech Pharma plc floated on the London stock market. It is the third biotech IPO on the AIM market this year.

CooperationAustria

05.12.2014 Austrian contract research company VTU has entered into a development and commercialisation agreement with US company RCT. The partners want to combine both companies' Pichia pastoris protein production technologies under VTU's roof.

FinancingDenmark

03.12.2014 Danish biotech pharma Ascendis has successfully completed a €48m Series D financing round. The funding is expected to support its late-stage clinical trials to push its lead drug into Phase III trials.

RegulationUKFranceGermanySpain

01.12.2014 In spite of innovative new medicines on the market, the UK and Germany lag behind other countries and continue to use older medicines - especially in the treatment of cancer. French and Spanish patients, on the other hand, benefit much earlier from medical innovation.

Events

All Events

Current issue

All issues

Product of the week

Products