Welcome to your Regulatory Index News update. Safety signals lead to altered situations for two products where another has been accepted for EU review.
Allergan’s Esmya US verdict delayed due to EU liver injury cases
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) are currently investigating Esmya for liver safety and now the FDA have told Allergan that they will require three more months to review the new drug application, meaning an August deadline. The PRAC review is down to several cases (now 5) of serious liver damage which required liver transplantations. For this reason, it is found unsurprising that the FDA have pushed back the review deadline in order to perform their own investigations. An Allergan spokesperson has however released a statement suggesting continued confidence in FDA approval, in that they still believe the total data for Esmya backs a positive benefit-risk profile. Please click here if you would like to read further from a FiercePharma article.
Biogen and AbbVie withdraw MS drug from market due to safety signals
A statement was released by Biogen and AbbVie last week that they were voluntarily withdrawing Zinbryta, their multiple sclerosis (MS) drug, from the market after reports of inflammatory encephalitis and meningoencephalitis. Zinbryta is a third-line treatment for relapsing MS but has safety issues denoted by a boxed warning for liver and immune system problems, and thus has only been used by a small number of patients. In response to the adverse event reports, the EMA have issued an Article 20 procedure whereby the Pharmacovigilance Risk Assessment Committee (PRAC) may require further information and the companies may incur fees. If you would like to read into this, please click here for a BioPharmaDIVE article.
EMA accepts AstraZeneca’s Forxiga filing for type I diabetes
Forxiga is a first-in-class SGLT-2 inhibitor that has been on the EU market since 2012 to treat type II diabetes. AstraZeneca now however have clinical data to support efficacy in type I diabetes so have filed for this in the EU, which the EMA have agreed to review. The Phase III trial (DEPICT) data which supports this showed that Forxiga, as an oral adjunct to adjustable insulin, significantly reduced HbA1c, weight and total daily insulin doses at 24 and 52 weeks when compared with placebo in inadequately-controlled type I diabetes patients. The safety profile was also found alike to that for type II diabetes treatment other than increased diabetic ketoacidosis (DKA) events. Please click here to read more from a PharmaTimes article.