Horizon Pharma Seeks Approval for New RA Drug

Horizon Pharma, Inc, announced late last month that it had submitted a new drug application to the FDA for LODOTRA, a delayed-release formulation of low-dose prednisone to treat rheumatoid arthritis (RA). The drug is currently approved in 16 European countries.

The submission was based in part on results of the Circadian Administration of Prednisone in RA (CAPRA-2) trial, a 12-week, Phase 3 trial including 350 RA patients. In the trial, both the experimental and the control groups received standard RA treatment with a disease-modifying anti-rheumatic drug.

The results found that 48.5% of those receiving LODOTRA experienced at least a 20% improvement in signs and symptoms of RA (a measure known as ACR20) compared with 28.6% of those in the control group; 22.7% of those receiving LODOTRA experienced at least 50% improvement in RA signs and symptoms (ACR50) compared with 9.2% of the control group; and 7.0% had at least 70% improvement (ACR70) compared with 2.5% of the control group. In addition, 56.5% of those receiving LODOTRA experienced reduction in morning stiffness compared with 33.3% of the control group.

The submission also included results from the CAPRA-1 study, a 12-week study in Europe on 288 RA patients that compared night-time administration of LODOTRA with morning administration of immediate-release prednisone at the same individual dose. It found that 22.7% of those receiving LODOTRA experienced a reduction in morning stiffness compared with 0.4% in the group receiving immediate-release prednisone. In addition, patients receiving LODOTRA had a reduction in IL-6 levels of approximately 29%, while the IL-6 levels of those treated with immediate-release prednisone remained constant.

Source

Horizon Pharma Submits New Drug Application for LODOTRA(R) for the Treatment of Rheumatoid Arthritis [Press Release]