What was the recommendation o
f the CHMP at that time?
ased on the review of the data
and the compan
to the CHMP lists
of questions, at the
time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that
could not have been approved.
particular, the CHMP was concerned
results indicating that Omontys
risk of death
heart and circulatory problems
patients treated for the first time
medicines for stimulating red blood ce
production. The Committee was also concerned by
the results of inspections
that the study
In addition, the CHMP was concerned by reports of serious
ensitivity (allergic) reactions, including f
led to the removal of Omontys from the
market in February 2013
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of
weigh its risks.
Its funny no one has pointed out that the chmp does not have the final say and just makes suggestions to the EMA, and for themost part 2/3 of drugs get negative ratings but 1/3 make it through despire that.
If O is causing the issue unsure when the Trial is still ongoing for the other indications and that too 7th year in a Row.
Secondly it is all about First day Allergic reactions. Obviously they need to conduct some initial tests for the new patients to ensure they are OK with Omontys. Every drug causes reactions and my father-in law had a blood thinner administered made by Baxter (I don't remember that name) and he had near death reaction for him. Dr's were present to resurrect him otherwise he would have passed away.
It is just ensuring they are tolerant to specific medication is vital and O will get thru this issue soon.
Jagan- thanks for staying focused on the issue with Omontys. Everything else is just noise.
I also believe that the solution is easy, come up with a simple test to determine if a patient will have an allergic reaction to O before first dosing. End of story!
I also think that Takeda have already completed the investigation and are stalling for time to put a plan together for reintroduction to market or negotiating a buyout. There is a slim chance for bankruptcy...