Merck KGaA holds marketing rights to LODOTRA® in Germany and Austria, and Mundipharma holds marketing rights to LODOTRA® in the rest of Europe.
The company has completed a Phase 3 trial for LODOTRA® in the U.S. for the treatment of the signs and symptoms of RA. In the pivotal U.S. Phase 3 clinical study (CAPRA-2), patients treated with LODOTRA® experienced a statistically significant improvement in ACR-20 response when compared with patients in the placebo group (48.5 percent vs. 28.6 percent; p=0.0002). In addition, patients taking LODOTRA® experienced a statistically significant improvement in ACR-50 response (22.7 percent vs. 9.2 percent; p=0.0027). Importantly, patients treated with LODOTRA® also experienced a statistically significant reduction in morning stiffness when compared with patients in the placebo group (44 percent vs. 21 percent; p=0.0008).
LODOTRA® is also being investigated for the treatment of severe asthma and polymyalgia rheumatica (PMR).