PRAC News – April 2016


In April, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started a new safety review, extended the scope of an ongoing review procedure and agreed the rules of procedure for public hearings.

PRAC reviews diabetes medicine canagliflozin

The PRAC has started a review of the diabetes medicine canagliflozin after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. Canagliflozin is the active substance in two centrally authorised diabetes medicines, Invokana and Vokanamet (which also contains metformin).

More information is available on the HALMED portal.

PRAC extends the scope of its review on direct-acting antivirals for hepatitis C

The PRAC also extended the scope of its ongoing safety review of medicines known as direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi, Viekirax) used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

At its previous meeting in March, the Committee had initiated a review following cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C.

In April 2016, data from a study became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with these medicines. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines.

More information is available on the HALMED portal.

Rules of procedure on public hearings on selected safety reviews adopted

The PRAC has adopted the final rules of procedure for public hearings to be held by the Committee. The rules of procedure describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings. Public hearings are a new tool for EMA to engage European Union (EU) citizens in the supervision of medicines and to listen to their views and experiences.

More information is available on the EMA website.

More information on the April 2016 PRAC meeting can be found here.