CARLSBAD, CA, USA I March 22, 2013 I Isis Pharmaceuticals Inc. (ISIS) today announced that following Genzyme’s request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMROTM (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH).
The FDA approved KYNAMRO in the United States in January 2013 for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
About Isis Pharmaceuticals, Inc.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis’ broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare diseases, and cancer. Isis’ partner, Genzyme, is commercializing Isis’ lead product, KYNAMRO, in the United States for the treatment of patients with HoFH. Genzyme is also pursuing marketing approval of KYNAMRO in other markets. Isis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
SOURCE: Isis Pharmaceuticals
Post Views: 161
CARLSBAD, CA, USA I March 22, 2013 I Isis Pharmaceuticals Inc. (ISIS) today announced that following Genzyme’s request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMROTM (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH).
The FDA approved KYNAMRO in the United States in January 2013 for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
About Isis Pharmaceuticals, Inc.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis’ broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare diseases, and cancer. Isis’ partner, Genzyme, is commercializing Isis’ lead product, KYNAMRO, in the United States for the treatment of patients with HoFH. Genzyme is also pursuing marketing approval of KYNAMRO in other markets. Isis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
SOURCE: Isis Pharmaceuticals
Post Views: 161
