Positive Phase III Results Bring Nitec Closer to FDA Submission of RA Therapy
Lodotra is available in Germany and has an approvable status across Europe.
Nitec Pharma’s single-pulse, delayed-release prednisone tablet, Lodotra™, succeeded in a second Phase III trial in patients with rheumatoid arthritis (RA). The company says that data from this study called CAPRA-2 and previous CAPRA-1 trials will form the basis of a regulatory submission to FDA.
The CAPRA-2 trial included 350 RA patients who demonstrated inadequate responses to DMARD therapies. Participants received either Lodotra or placebo in addition to their existing medication. The primary efficacy endpoint was at least a 20% improvement in a number of disease-specific criteria defined as the ACR-20 response rate.
Results showed that 49% of Lodotra-treated patients achieved an ACR-20 response compared with 29% of patients in the placebo group. Lodotra treatment also led to a 44% reduction in morning stiffness, more than double that in the placebo group.
Lodotra was launched in its first European market, Germany, in April this year by Merck KGaA, which holds exclusive distribution rights to the drug in that country and Austria. Germany is leading the decentralized European approval process for Lodotra.
During March Nitec granted Mundipharma distribution rights to Lodotra across the rest of Europe. Nitec has retained all commercialization rights in the rest of the world.