European regulators announced last week that they will investigate the safety of Sanofi-Aventis' Multaq following reports of serious liver damage linked with the heart drug.
The news comes hot on the heels of a decision across the pond to slap an extra warning on Multaq's (dronedarone) label informing patients and doctors about the potential risk of liver injury after the US Food and Drug Administration received several reports of hepatocellular liver injury and even two cases of hepatic failure - and the need for a subsequent transplant - in those treated with the drug.
The reports have spurred the European Commission to request that the Committee for Medicinal Products for Human Use take a look at all available data related to the Multaq's potential for liver injury and determine its impact on the benefit-risk balance for patients taking the drug.
At an earlier meeting this month the CHMP concluded that "urgent action" on the issue was warranted, and that warnings and precautions should be added to the medicine’s prescribing information to ensure that patients’ liver function is tested before treatment and that they are closely monitored while taking the drug.
A Direct Healthcare Professional Communication on severe liver injury associated with use of Multaq is now being circulated to healthcare professionals throughout Europe to ensure patient safety while regulators conducts a full investigation.
Multaq approved in the US and Europe (and other regions) in 2009 for the treatment of abnormal heart rhythm in patients, on the back of data from seven clinical trials, including one that showed that it cut the number of hospital days in patients with atrial fibrillation by 28% compared to placebo and the total length of time spent in hospital for heart-related reasons by 35%. The drug pulled in sales of 46 million euros in the third quarter of last year, but should hit $1.35 billion by 2014, according to consensus forecast compiled by Thomson Reuters.
Jevtana gets CHMP OK
In better news for Sanofi, the CHMP is recommending marketing approval for its prostate cancer drug Jevtana (cabazitaxel).
Specifically, the Committee has endorsed the use of Jevtana in combination with prednisone or prednisolone to treat patients with metastatic hormone-refractory prostate cancer (mHRPC) in those who have previously received therapy with a docetaxel-containing treatment regimen.
The decision was based on data from the Phase III TROPIC clinical study involving 755 patients which showed a statistically significant 30% cut in risk of death from mHRPC among in those taking the Jevtana regimen compared with patient given an active chemotherapy regimen. Furthermore, the median survival of patients receiving Sanofi's drug was 15.1 months, 2.4 months higher than patients receiving the chemotherapy mitoxantrone, the drugmaker said.
Jevtana has already been granted marketing authorisation in the Brazil and the US, where its performance has exceeded the firm's expectations, it said.
