I think a European Agency just recommended against its use in anymore trials.
- pat
Not true about the EMA- European Medical Agency.
It would not accept trial data from India due to European concerns over the quality of data and would not license Riluzole from Alkem Labs, India, in the EU.
Riluzole from European labs is not affected by this.
Here is the EMA Statement from 24 June 2016.
The European Medicines Agency (EMA) has recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU. The recommendations follow a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 20013 and 2014 at the Taloja site.
The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015.
EMA’s Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU.
Therefore, the Committee recommended that medicines authorised or being evaluated on the basis of these studies should be suspended or refused authorisation, unless alternative data are available from other sources. The specific recommendations of the CHMP are as follows:
• Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended.