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. 

You must be a registered member of MMM to post a comment.
 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.