« Return to News | Clinical Intelligence

FDA OKs Rayos for rheumatoid arthiris and more

Friday, July 27, 2012 10:31 AM

The FDA has approved Horizon Pharma’s Rayos (prednisone) delayed-release tablets (1mg, 2mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). 

The FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial supported the overall safety of Rayos.

"We are extremely pleased the FDA has approved Rayos for a broad range of indications, including RA and polymyalgia rheumatica," said Timothy P. Walbert, chairman, president and CEO, Horizon Pharma. "Our initial focus will be on the launch of Rayos in rheumatologic diseases such as RA and polymyalgia rheumatica in the fourth quarter of this year. Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for Rayos in key IL-6 mediated diseases, including asthma and COPD."

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.