Regeneron Pharmaceuticals ($REGN), the maker of a drug used solely to treat raregenetic inflammatory autoimmune diseases (Arcalyst), is meeting with the FDA this week in order to expand the drug’s usage so it can be used to treat gout.
However, the new drug usage was given a mixed review by the FDA staff, because even though gout symptoms of the men and women in the study improved, 6 of the study participants developed cancer while on the drug. The cons of the drug usage likely outweighed the pros, they said.
The reviewers also noted that they were unsure whether 16 weeks, the length of the study, is long enough for malignancies to appear. While in front of the panel, Regeneron Pharmaceuticals must convince the FDA panel members that Araclyst will greatly benefit consumers who suffer from gout significantly more than hurt them.
Source – Fiercebiotech.com