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Blow for Sanofi as EMA turns down cholesterol drug Kynamro

Points to safety concerns related to liver toxicity and cardiovascular events

Hopes for Sanofi's cholesterol drug Kynamro took a dent after a European Medicines Agency panel failed to recommend its use based on safety concerns.

The Committee for Medicinal Products for Human Use (CHMP) said that Kynamro (mipomersen), which is developed to treat patients with a genetic condition that leads to elevated levels of cholesterol, was effective at reducing levels of bad cholesterol, but the number of side effects was a concern considering the drug is intended for long-term use.

The decision comes shortly after the drug received narrow backing from an advisory committee to the US FDA for its use in the genetic condition homozygous familial hypercholesterolaemia (HoFH) despite the same safety concerns.

These mainly related to studies where patients taking Kynamro demonstrated a build-up of fat in the liver and increased enzyme levels, as well as increased risk of cardiovascular events.

“Therefore, at that point in time, the CHMP was of the opinion that the benefits of Kynamro did not outweigh its risks and recommended that it be refused marketing authorisation,” said the Committee.

Sanofi, which markets the drug in partnership with its initial developers Isis Pharmaceuticals, said it was disappointed with the decision and plans to request a re-examination of the CHMP opinion.

“Patients with HoFH carry extreme, ongoing cardiovascular risk with significantly elevated LDL-C levels despite use of currently available therapies,” said David Meeker, president and CEO of the Sanofi division Genzyme.

“This is a rare disease patient population, with a life-threatening condition, in need of new therapies. We will work closely with the CHMP during the re-examination process to address the Committee's concerns, with the goal of making this important medication available to HoFH patients in Europe.”

The drug is also currently under review in the US following the FDA advisory committee recommendation.

However, if approved, it is likely to face stiff competition from fellow HoFH treatment lomitapide from Aegerion, which received a committee recommendation of 13 to 2 compared to Kynamro's recommendation of 9 to 6.

17th December 2012

From: Sales



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