(By Balachander) ISIS Pharmaceuticals Inc. (NASDAQ: ISIS) shares tumbled in Friday premarket trading after an European Committee recommended the refusal of the marketing authorisation for its lead product Kynamro intended to treat high blood cholesterol levels, citing saftety concerns.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on Thursday adopted a negative opinion for Kynamro for the treatment of patients with an inherited disease causing high blood cholesterol levels, called familial hypercholesterolaemia.
The CHMP was of the opinion that the benefits of Kynamro did not outweigh its risks and recommended that it be refused marketing authorisation.
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The Committee noted that a high proportion of patients stopped taking the medicine within two years, mainly due to side effects such as flu-like symptoms, injections site reactions and liver toxicity. The Committee was also concerned that a greater proportion of patients taking Kynamro experienced serious cardiovascular events (problems with the heart and blood vessels) than patients taking placebo.
"This prevented the CHMP from concluding that Kynamro's intended cardiovascular benefit, in terms of reducing cholesterol levels, outweighed its cardiovascular risk," CHMP said.
Genzyme, a Sanofi company (NYSE: SNY) and ISIS' partner, plans to request a re-examination of the CHMP Opinion.
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In October 2012, KYNAMRO received a positive vote by an U.S. Food and Drug Administration (FDA) advisory panel that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO to treat HoFH.
ISIS shares dropped 8.95 percent in Friday pre-market trade.