FDA OKs Changes in Santarus Heart Study

Xconomy San Diego — 

The FDA has agreed to protocol changes in a late stage clinical trial of a new heart drug being developed by San Diego-based Santarus (NASDAQ: SNTS) and the Netherlands-based Pharming Group under a special protocol assessment (SPA). The FDA sought modifications to the study of a recombinant human C1 inhibitor (Rhucin) as a treatment for Hereditary Angioedema, a disorder that can trigger acute swelling of the limbs, face, windpipe, and intestinal tract. Under an SPA, the FDA provides early guidance on study protocols, smoothing the way to a new drug application.