Center for Excellence in Drug Safety and Pharmacovigilance

Drug Safety Business News

The impact of drug safety on clinical research and development is ever present.  CEDSPV serves as your guide to keeping on top of the latest developments in drug safety and its affects on clinical development programs around the globe.




December Drug Safety Business News

Merck’s Potential Blockcuster Tredaptive Fails Phase III Hurdle – Leads to EMA Analysis

Merck has released this week that its phase III program including greater than 25,000 patients for cholesterol lowering drug Tredaptive has been ended.  The large scale late phase study was unable to provide evidence that the product would prove effective at decreasing the likelihood of patients experiencing vascular events. Additionally, the study prompted concerns as the preliminary results noted greater numbers of serious adverse events than seen in those patients taking the more traditional cholesterol lowering medications known as statins.

Both Merck and the EMA have recommended that no new patients should be started on treatment with Tredaptive. The EMA’s Pharmacovigilance Risk Assessment committee will be conducting its own review of the company’s clinical trial data and will issue a recommendation expected in January 2013.

For more information please see the EMA’s Press release here.

Safety Concerns Lead to EMA Negative Opinion for Sanofi’s Cholesterol Drug Mipomersen

Citing issues of cardiovascular and liver toxicity European regulators have given a negative opinion to Sanofi’s mipomersen. The product, which is specifically designed for patients with a genetic disorder, homozygous familial hypercholesterolemia, had won approval from the FDA in October of 2011, but failed to impress the EMA’s Committee for Medicinal Products for Human Use.  Sanofi is expected to request a second look from the agency.

For more information see Genzyme’s ( a Sanofi Company) press release here.

Vanda Pharmaceutical’s Fanaptum for the Treatment of Schizophrenia Risks Outweight Benefits for EMA

“The CHMP concluded that the short-term effectiveness of Fanaptum in studies was modest when compared with placebo, and that longer-term effectiveness has not been shown sufficiently. The CHMP noted that Fanaptum has a delayed onset of action, which it considered to be a disadvantage. In terms of safety, the CHMP was concerned about the medicine’s effects on the heart: Fanaptum was shown to make the ‘QT interval’ (part of the heartbeat) to last for longer than normal. This side effect, called ‘QT prolongation’, can lead to arrhythmias (irregular heartbeats). The Committee considered that this risk was significant and not manageable by the risk-minimisation measures proposed by the company.”

Vanda Pharmaceuticals has released that it intends to resubmit its application for reconsideration.

For more information on the EMA’s decision click here.

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