Friday, 20 January 2012

Fingolimod to be reviewed by EU and US after 11 deaths

Breaking news:


European and U.S. regulators are reviewing Novartis AG’s Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months......

For full report see Bloomberg

4 comments:

  1. Are the 11 deaths from patients who were on Gilenya after it had been approved? Or were these patients on Gilenya while it was still in the pre-approval clinical trial phase?

    ReplyDelete
  2. This is very worrying what does it mean for us in the UK?

    ReplyDelete
  3. Re: "Are the 11 deaths from patients who were on Gilenya after it had been approved? Or were these patients on Gilenya while it was still in the pre-approval clinical trial phase?"

    All the these patients have died after the drug has been approved. We will hear more about the deaths in the next few days. As far as I know they are unexplained, with several sudden deaths. The latter is worrying as fingolimod has a lot of off target effects including effects on the heart.

    ReplyDelete
  4. Re: "This is very worrying what does it mean for us in the UK?" At the moment this should not change things in the UK. We still do not have this drug available under the NHS. In addition the EU license is restricted to patients with highly active disease. Therefore the risk benefit ratio is very different to the US where it is being used as a first line therapy. We will keep you posted as new information enters the public domain.

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.