FDA approves sNDA for Xeljanz
Pfizer said yesterday that FDA approved a supplemental New Drug Application (sNDA) to update the label of RA pill Xeljanz to include radiographic data from two Phase-III studies, ORAL Scan and ORAL Start.
The updated US label will now include the radiographic response data from ORAL Scan (Study IV) at 6 months and ORAL Start (Study VI) at 6 and 12 months. These studies evaluated the effect of the drug on the progression of structural joint damage.
The ORAL Start study showed that Xeljanz was superior to methotrexate by a statistically significant margin in inhibiting progression of structural joint damage, while the ORAL Scan study showed Xeljanz reduced progression of structural joint damage more than placebo.