Johnson & Johnson's Stelara gains FDA approval for psoriatic arthritis

23 September 2013

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), announced that the US Food and Drug Administration (FDA) has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis.

For the treatment of psoriatic arthritis, Stelara is administered as a 45 mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks, thereafter. The approval is supported by findings from two pivotal Phase III multicenter, randomized, double-blind, placebo-controlled trials of Ustekinumab, a fully human anti-il-12/23p40 monoclonal antibody, administered subcutaneously, in subjects with active psoriatic arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously-administered Stelara 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks.

Cindy Guzzo, vice president, medical affairs, Janssen Biotech, said: "We're proud to expand our portfolio of biologic treatment options for patients living with psoriatic arthritis to include an anti-IL-12/23 therapy such as Stelara. The efficacy and safety profile of Stelara, coupled with a dosing regimen of every 12 weeks after two starter doses, makes this a meaningful new option for patients battling this chronic condition.”

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology