The European application is very exciting!
European regulatory philosophy is they look at the disease and treatment alternatives, safety is considered (no one disputes safety of Myotrophin) and then decide from a medical perspective on approval. This process usually results in earlier approval of European drugs. The US FDA counters that the European approach results in greater risk to patients, .... Anyone who understands the terminal nature of this horrible disease (it's worse than most cancers or AIDS), can't get too concerned about the chance of undo risks caused by the European approach. I believe most neurologists who treat ALS patients would support availability of this agent (Dr Munsat, President of the World Neurology Association spoke out in favor of approval at the Panel Meeting). It is my understanding Myotrophin has a reasonable chance for approval in Europe this fall regardless of what the US FDA decides.
Imagine the U.S. ALS patient being deprived of something available in Europe...certainly this happens all the time, but the political repercussions when you're dealing with this morbid of a disease are huge, and certainly will be on the minds of the FDA, esp Dr. Temple.
It also bodes well for the company, they will have sales also, and I would wonder if the FDA did require additional testing, if CEPH/CHIR would go ahead and just market myotrophin in Europe and continue with ongoing evaluations there, but tell the FDA, "No more Phase III's, if you don't want the drug, you go justify to the US ALS patient why they can't have it here". Besides who want to be a part of a study when you have 50% chance of being given a placebo instead of a drug already approved and shown to be effective? |
