EMA cites heart issues in Qsiva’s rejection

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The European Medicines Agency (EMA) once again gave a cold shoulder to Qsiva as a treatment for severely obese or obese patients, citing concerns about long-term cardiovascular effects.

Qsiva (Vivus) was proposed as a treatment for obese patients with hypertension, type 2 diabetes, dyslipidemia and other weight-related problems. Vivus had asked for a re-examination after the Committee for Medicinal Products for Human Use (CHMP) recommended in 2012 that Qsiva be refused marketing authorization.

Qsiva contains two appetite suppressants: phentermine and topiramate. Studies have shown clinically relevant weight loss following treatment with Qsiva but CHMP questioned the medicine's long-term effects on the heart and blood vessels. Phentermine is known to increase heart rate and and topiramate also is known to potentially harm the unborn baby if taken by a pregnant woman.

CHMP also noted that there was a high probability that, if approved, the medicine would not be used strictly for the intended patients. Vivus proposed measures to reduce this risk, but the committee considered them difficult to implement in practice.