Eli Lilly reports positive phase 4 results for cholesterol drug, prompting US labeling change Print E-mail
By Olivia D'Orazio - Proactiveinvestors.com   
Monday, 18 July 2011 14:33
Eli Lilly (NYSE:LLY) and Kowa Pharmaceuticals America announced Monday that a phase 4 study of pitavastatin, marketed as LIVALO, found minimal interaction between a 4 milligram (mg) dose of the cholesterol drug and a combination drug used to treat HIV, protease inhibitors lopinavir/ritonavir.

The FDA-mandated study found that when co-administered, the drug blood levels for LIVALO, or each of the protease inhibitors, were minimally affected, Eli Lilly said.

The results of this study, which was designed to assess the effect on the overall exposure in the body, have prompted the FDA to approve a labeling change to the U.S. LIVALO package, deleting the lopinavir/ritonavir limitation of use label.

LIVALO, which was launched in the U.S. in June 2010, and is approved in Japan, South Korea, Thailand, China, Taiwan, Lebanon, and the European Union, works by inhibiting cholesterol production in the liver, reducing total cholesterol, and low-density lipoprotein cholesterol, or the bad form of cholesterol, and triglycerides.

The drug also increases high-density lipoprotein cholesterol, or the "good" cholesterol.

Elevated levels of cholesterol are common side effects in patients with HIV. Over 66% of HIV sufferers have high cholesterol and are taking anti-retroviral meds, like the lopinavir/ritonavir combination.

"[HIV] patients are frequently on multiple medications and the management of [cholesterol] can be even more of a challenge," said Kowa vice president of medical affairs, Craig Sponseller.

"We are pleased with the results of this study and the absence of a significant drug interaction when LIVALO is co-administered with this combination of protease inhibitors."

The second endpoint of the study, which was to examine the safety of LIVALO when interacting with the lopinavir/ritonavir combination, was also met, as no severe adverse effects were recorded, Eli said.

In late 2009, Eli Lilly and Kowa announced a partnership that would see Eli Lilly promote and market the Japanese company's LIVALO drug in the U.S. Eli Lilly also earned the licensing rights to commercialize LIVALO in South America.


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