EMA committee says AB Science’s Masitinib should not be approved in light of GCP failings
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) announced its recommendation last week.
The committee said it is “concerned about the reliability of the study results because a routine GCP (good clinical practice) inspection at the study sites revealed serious failings in the way the study had been conducted."
The Committee also raised concerns about protocol changes made “while the study was ongoing, which made the results difficult to interpret” and added that it has doubts about side effect data.
Masitinib is a protein kinase inhibitor being developed for a range cancers, inflammatory disorders and neuro-degenerative diseases. It is being examined in multiple Phase III studies at sites across Europe.
GCP problems
The GCP failings came to light two weeks ago when France’s Agence Nationale de la Sécurité des Médicaments (ANSM) told AB Science to suspend French masitinib studies (here in French). The regulator said it had uncovered problems during a review of a trial conducted between 2009 and 2015.
At the time AB Science pointed out it had implemented a new quality system in mid 2015, after the study reviewed by ANSM was conducted.
It also said: "An independent audit will be performed in the coming months in order to provide ANSM with confirmation that the system meets the GCP standards. ANSM confirmed that the clinical studies could restart in France following the positive results of this audit plan."
The firm did not respond to a request for comment about the CHMP recommendation.
