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The FDA nods to Vyepti, Esperions Nexletol and Karius Series B. BUSINNESS


Formerly known as eptinezumab, Vyepti von Lundbeck has received the FDA’s recommendation to prevent adult migraines.

It is estimated that women are twice affected compared to men, with around 1.3 billion people worldwide and around 38 million people in the United States affected by migraines.

With the green signal to Lundbeck, it will become a new member of the migraine treatment market, who is already raving about the new therapies from pharmaceutical companies such as Teva, Amgen and Eli Lilly.

Vyepti is the first intravenous drug to receive approval and will be available to patients from April this year. Vyepti, a humanized monoclonal antibody, binds to the calcitonin gene-related peptide (CGRP) ligand, blocking its binding to the receptor. So far, Anti-CGRP drug treatment was the mainstay in the migraine treatment market. The drug acquired from Alder Biopharmaceuticals will compete fiercely with that from Teva Ajovy, Amgens Aimovig and Lillys Emgalität,

Michigan-based lipid management company Esperion has announced the FDA for its LDL cholesterol-lowering drug Nexletol.

A once-a-day, premium ATP citrate lyase (ACL) inhibitor, Nexletol (Bempedoic acid) lowers LDL cholesterol (LDL-C) by stopping cholesterol synthesis in the liver. The first oral therapy, Nexletol has been recommended for the treatment of patients with heterozygous familial hypercholesterolaemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require an additional reduction in LDL-C.

Other anti-cholesterol therapies like Praluent and RepathaNexletol, which is administered intravenously, has the upper hand over the convenient route of administration. In addition, Esperion’s drug will cost comparatively less than the other available on the market and will be launched in March.

The company also hopes to see positive results for its other LDL-C lowering drug – bempedoic acid and ezetimibe combination tablet – which is known to lower low-density lipoprotein cholesterol and cholesterol absorption, respectively.

Karius – a California-based start-up that focuses on liquid biopsy tests – raised USD 165 million in the B series.

The round was led by SoftBank Vision Fund 2 together with the participation of General Catalyst, HBM Healthcare Investments and the existing investors Khosla Ventures and LightSpeed ​​Venture Partners.

Liquid biopsies have gained momentum in recent years as they can easily identify foreign biomarkers, genetic material in body fluids – blood and urine – to identify tumors, perform prenatal tests, and others. In the same way, the company manufactures pathogen detection tools using DNA sequencing and machine learning techniques.

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