Contract awarded for code igss 10,577 atorvastatin calcium / ezetimibe
, coated tablet 40 mg / 10 mg
CHICAGO -- Adding ezetimibe
to a midpotency statin in high-risk heart disease patients to drive their LDL cholesterol into the low 50s resulted in a further significant reduction in major cardiovascular events, compared with statin alone, in the 18,144-patient IMPROVE-IT study.
Healthcare company Merck (NYSE:MRK) (MSD outside the US and Canada) announced on Wednesday that the US Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe
and atorvastatin tablets, an investigational combination medicine.
The agency has put the application for a fixed-dose combination of ezetimibe
and atorvastatin back in the anufacturer's court with a request for more data, according to Merck.
We believe that IMPROVE-IT showed that ezetimibe
in combination with a statin offers a significant benefit to high-risk patients with coronary heart disease (CHD) and are committed to continuing to work with the FDA so that they can complete the review of our request for new indications for VYTORIN and ZETIA (ezetimibe
At baseline, all were above their LDL goal despite maximally tolerated statin therapy, in two-thirds of cases with add-on ezetimibe
In a press release, Merck, the manufacturer of ezetimibe
(Zetia) and Vytorin - a combination of ezetimibe
and simvastatin - said that the FDA had approved the new labeling that now includes data from the Study of Heart and Renal Protection (SHARP).
Esperion announced positive top-line results from the first pivotal, Phase 3 study of bempedoic acid 180 mg evaluating the LDL-C lowering efficacy and safety and tolerability of bempedoic acid versus placebo in patients with atherosclerotic cardiovascular disease or at high risk for ASCVD with hypercholesterolemia inadequately treated with background ezetimibe
10 mg and up to the lowest daily starting dose of a statin.
bumps that figure up to 86 percent.
M2 PHARMA-June 13, 2017-Zydus Cadila and Sun Pharma granted US approval to market ezetimibe