Lilly's Pancreatic Enzyme Replacement Therapy Faces Advisory Committee Scrutiny
This article was originally published in The Pink Sheet Daily
FDA's Gastrointestinal Drugs panel's Jan. 12 review of Solpura (liprotamase) is likely to focus on robustness of efficacy results and relevant endpoints.
You may also be interested in...
Alnara hopes to leverage Lilly's prior success with recombinant insulin products.
Alnara claims its latest trial shows real-world effectiveness of liprotamase, formerly called Trizytek, and plans early 2010 NDA.
FDA is not removing unapproved products from the market because they are medically necessary. However, manufacturers must obtain approval of exocrine pancreatic insufficiency drugs within four years.