Kowa Pharmaceuticals America, Inc., a specialty pharmaceutical company, engages in the acquisition, development, licensing, and marketing of pharmaceutical products. The company focuses on cardiometabolic therapeutics. It offers LIVALO, which is an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (Apo B), and triglycerides; and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. The company also provides LIPOFEN (fenofibrate capsules), which is indicated as an adjunctive therapy to diet to reduce elevated triglycerides and to increase high density lipoprotein cholesterol in adult patients...
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Montgomery, AL 36117
Founded in 2001
Kowa Pharmaceuticals America, Inc. Announces Presentation of New Data from the Intrepid
Jun 21 16
Kowa Pharmaceuticals America, Inc. announced the presentation of new data from the INTREPID (HIV Patients and treatment with Pitavastatin versus PravastatIn for Dyslipidemia) trial, showing pitavastatin significantly lowered key arterial inflammation and immune activation markers in HIV patients on chronic antiretroviral therapy (ART) compared to pravastatin, a commonly prescribed statin for HIV-infected patients with dyslipidemia. Combined with previously reported INTREPID data demonstrating superior LDL-C reduction with pitavastatin versus pravastatin (-31% vs. -21%, respectively), results suggest pitavastatin may be an ideal statin to optimally improve lipids and inflammatory markers in HIV patients. INTREPID was a randomized, double-blind, double-dummy, active-controlled, parallel-group, superiority trial conducted at 45 sites in the United States and Puerto Rico. Participants included 252 HIV-infected males and females on ART for more than six months. Select inflammatory and immune activation biomarkers were assessed at baseline, Week 12, and Week 52. Participants were randomized 1:1 to receive pitavastatin 4mg once daily and a matching pravastatin placebo vs. pravastatin 40mg once daily and a matching pitavastatin placebo. Baseline demographics including gender, total cholesterol, log HIV RNA, CHD risk score, nor baseline levels of inflammatory markers were not different between the treatment groups. At Week 52, participants randomized to pitavastatin demonstrated significantly greater reductions in sCD14 (-8.2% vs. 0.6%; P=0.007), oxLDL (-26.6% vs. -17.6%; P=0.02) and Lp-PLA2 (-25.0% vs. -14.9%; P=0.003), compared to participants randomized to pravastatin. Changes in other markers were similar between the groups at 52 weeks. Superior LDL-C reductions were seen in the pitavastatin group (-31% vs. -21% pitavastatin vs. pravastatin). Adverse event profiles and overall safety were maintained and remained similar for both pitavastatin 4 mg and pravastatin 40 mg.