FDA approves Genzyme drug for rare cholesterol disorder
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.
The FDA announced the approval of Kynamro (mipomersen sodium), made by Genzyme for the treatment of homozygous familial hypercholesterolemia, or HoFH. Kynamro has been approved as an orphan drug, a designation the FDA gives to drugs that treat diseases affecting fewer than 200,000 people.
The disease is an inherited condition affecting about one-in-1 million people in the United States and prevents the body from removing low-density lipoprotein cholesterol from the bloodstream. For people with HoFH, heart attacks and death often occur before age 30.
"Kynamro, an injection given once a week, works with other lipid-lowering medications and diet to impair the creation of the lipid particles that ultimately give rise to LDL-C," FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said.
The FDA approved another drug for HoFH, Aegerion Pharmaceuticals’ Juxtapid (lomitapide), in December 2012.
Eli Lilly reports 1% Q4 decline from Zyprexa patent expiration
INDIANAPOLIS — Eli Lilly and Company on Tuesday reported that its fourth quarter revenue for the period ended Dec. 31 declined 1% to $6 billion because of its Zyprexa patent expiration. Full-year 2012 revenue declined 7% to $22.6 billion.
"Lilly delivered solid financial results in the fourth quarter of 2012, as we successfully offset a large part of the revenue decline from the Zyprexa patent expiration with growth in other products such as Cymbalta, Forteo, Alimta, Effient and our animal health portfolio," stated John Lechleiter, Lilly’s chairman, president and CEO. "At the same time, we continued to control costs while investing in R&D in order to replenish and advance our pipeline. Today, Lilly has 13 potential new medicines in Phase III testing. We are well-positioned to deliver on our innovation-based strategy and create long-term value for all of our stakeholders."
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New York Times: Battle against biogenerics is on
NEW YORK — The battle against biogenerics is on, noted a report published in The New York Times Tuesday. As many as eight states have introduced legislation that would restrict generic competition of biological pharamceuticals so far this year and one, the Virginia House of Delegates, already passed such a measure by a 91-to-6 vote.
At the federal level biological manufactures are squaring off against their potential generic competitors on whether or not the generic equivalent can share the same generic name as the brand product, the NYT report noted. If no, then pharmacists will be unable to substitute one for the other even if a state were to allow biogenerics.