New EU Restrictions On Biogen’s MS Drug Zinbryta Are ‘Damaging’, Analyst Warns
Biogen is to continue to work closely with the EMA on clear guidance on how to use its MS drug Zinbryta, after the regulators recommended further restrictions on the product’s use because of the risk of liver damage. But an analyst says the restrictions are detrimental for the drug.
You may also be interested in...
Biogen/AbbVie’s Zinbryta is already being withdrawn worldwide, but EMA now wants the MS drug recalled after mounting reports of serious brain disorders.
Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.