Amgen's world's first PCSK9 inhibitor Repatha is approved by the European Union
July 22, 2015 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Biogen giant Amgen has recently achieved significant milestones in regulation. The company's PCSK9 inhibitor Repatha (evolocumab) has been approved by the European Union, marking the birth of the world's first new generation of PCSK9 inhibitor lipid-lowering drugs! However, Sanofi's PCSK9 inhibitor Praluent is likely to receive FDA approval this Friday, becoming the first new generation of PCSK9 inhibitor lipid-lowering drugs in the US market.
PCSK9 inhibitors are a class of monoclonal antibodies that target a protein called proprotein convertase subtilisin 9 (PCSK9), which reduces liver clearance of low-density lipoprotein cholesterol (LDL-C) from the blood. Capacity, while LDL-C is recognized as a major risk factor for cardiovascular disease (CVD). PCSK9 inhibitors offer a completely new treatment model against LDL-C, which is considered to be the biggest advancement in lipid-lowering after statins such as Lipitor and Zocor.
In this round of R&D competition, Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab) are in the lead, Pfizer's bococizumab is slightly behind, and Novartis, Roche and Merck are trying to catch up.
Interestingly, in the US market, Amgen Repatha was originally in the lead, but Sanofi spent an unprecedented $67.5 million in the sprint phase to buy an accelerated review voucher, shortening the Praluent review cycle from the normal 10 months. Up to 6 months, achieve beyond Amgen. In early June of this year, the FDA expert committee agreed to approve Praluent and Repatha respectively. The FDA has designated two products for the PDUFA target dates of July 24 and August 27, 2015 respectively. This also means that Praluent is likely to get the FDA approval this Friday and become the first PCSK9 inhibitor lipid-lowering drug in the US market.
Specifically, the European Union has approved Repatha for:
- primary hypercholesterolemia (familial and non-familial heterozygous) and mixed hyperlipidemia : (a) a supplementary diet combined with a statin or statin and other lipid-lowering drugs, Adults with a maximum tolerated dose of statin that are still unable to achieve LDL-C treatment goals; (b) Auxiliary diet, as monotherapy or in combination with other lipid-lowering drugs, for intolerance or contraindications to statins Adult patients. The recommended dose for Repatha is: 140 mg (every 2 weeks) or 420 mg (once a month), which are clinically equivalent. In clinical trials, Repatha significantly reduced LDL-C levels by 55%-75% compared to placebo, and Repatha significantly reduced LDL-C levels by 35%-45% compared to the cholesterol-lowering drug Zetia (ezetimibe, ezetimibe). And greatly improve other lipid parameters.
- homozygous familial hypercholesterolemia (HoFH) : combined with other lipid-lowering drugs for adolescents and adults aged 12 years and older. The initial recommended dose for Repatha is 420 mg (once a month), and if no remission has been achieved after 12 weeks of treatment, the dose is adjusted to 420 mg (every 2 weeks). In clinical trials, Repatha significantly reduced LDL-C levels by 15%-30% compared to placebo. After long-term treatment, the efficacy of lowering LDL-C can be maintained.
Repatha is a subcutaneous drug that is banned from intravenous or intramuscular injection and can be injected into the skin of the abdomen, thighs and upper arm. This drug should not be injected into areas of delicate, bruised, reddened or indurated skin. Patients need to exclude some secondary factors (non-hereditary) that cause hypercholesterolemia or abnormal blood lipid levels before starting Repatha treatment. At present, the impact of Repatha on cardiovascular disease morbidity and mortality has not been determined.
In Europe, 60% of high-risk patients taking statins or other listed lipid-lowering drugs still do not adequately control their LDL-C levels. In the very high-risk patient population, this proportion is as high as 80% or more. It is estimated that the annual health care costs of cardiovascular disease (CVD) in the EU are as high as 106 billion euros (about 109.8 billion US dollars).
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Fucus is a brown algae that grows on rocks along the shore.It grows on the coast of Brittany, France, where Marine life is rich and can be harvested at low tide.Its algal body is black brown, into double forked branches, for flat hornlike leaves.Its moisturizing properties, glutamate, can increase the skin's softness and smoothness.Brittany women use a combination of fucus and other Marine plants to make a moisturizing lotion that sooths their skin after the sun.
A type of brown algae that grows on rocks along the coast of Brittany, France, where Marine life is abundant, can be harvested at low tide.Its algal body is black brown, into double forked branches, for flat hornlike leaves.Its moisturizing properties, glutamate, can increase the skin's softness and smoothness.Brittany women use a combination of fucus and other Marine plants to make a moisturizing lotion that sooths their skin after the sun.
Order Fucales the highest order of the brown algae phylum.Algal bodies are perennial, flat or cylindrical, branching biformosely or radially around the main trunk.Apical growth, each epidermal cell has several disk-like chromatophores.Except for Fucus, there is no protein nucleus and no asexual reproduction in their life history.With or without airbags.Only sporophytes have no independent gametophytic stage in their life history. There are 350 species of 36 genera in 6 families, all of which are seafood.Most of them are distributed in tropical and subtropical oceans, and some are distributed in cold zones.There are 66 species of 5 genera and 3 families in China.
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