Biopharma Business

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed the safety reviews of a variety of medications during its June 2017 meeting. The medicines in review included treatments for multiple sclerosis, cancer, and products containing valproate.

The agency stated in a press release that PRAC had begun review of Zinbryta (daclizumab) because of reports of serious liver injuries associated with use of the drug, including one death from fulminant liver failure. Zinbryta is used to treat multiple sclerosis. PRAC will evaluate available data to “determine whether there are any implications for the use of the product and if there is a need to introduce any new measures to minimize the risk of liver damage,” the agency stated in the release.

PRAC also released its finding on the risk of neutropenic enterocolitis in patients treated with docetaxel. The committee determined there was no evidence of increased risk of the inflammatory condition in patients who use the cancer medication. EMA stated in the release that “the recent rise in reporting of the condition observed in France could be due to increased awareness among healthcare professionals. Reporting rates in the European Union as a whole do not provide any evidence of an increase in the incidence of neutropenic enterocolitis.”

During the meeting, PRAC announced it was scheduling the first public hearing of a drug safety review. The hearing, which was set for Sept. 26, 2017, will discuss the safety of the use of valproate-containing drugs used by pregnant women. Medicines containing valproate are used to treat epilepsy, bipolar disorders, and migraines. The committee said it will use the experiences of patients who have used the drugs in its evaluation of the drugs’ safety.