US approval to Lundbeck’s Vyepti for preventive migraine care; Esperion’s cholesterol-lowering drug Nexletol receives FDA nod; Karius – a start-up company – raises USD 165 Million – strengthens it liquid biopsy testing

Formerly known as eptinezumab, Lundbeck’s Vyepti has received the recommendation from the US FDA for preventing migraine in adults.

Estimated to affect women twice as compared to men, around 1.3billion people worldwide, and approximately 38 million people in the US are afflicted with Migraine. 

With the green signal to Lundbeck, it becomes a new member in the Migraine treatment market, which is already swarming with the new therapies by pharma giants including Teva, Amgen and Eli Lilly. 

Vyepti is the very first intravenous medication to receive the approval and will be available to patients from April this year. A humanized monoclonal antibody, Vyepti binds to calcitonin gene-related peptide (CGRP) ligand thus blocking its binding to the receptor. So far, anti-CGRP drug treatment has been the mainstay in the Migraine treatment market. Acquired from Alder Biopharmaceuticals, the drug is going to fiercely compete with Teva’s Ajovy, Amgen’s Aimovig and Lilly’s Emgality.

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

A once-daily, first-in-class ATP Citrate Lyase (ACL) inhibitor, Nexletol (bempedoic acid) lowers down the LDL-Cholesterol (LDL-C) by halting the synthesis of cholesterol in the liver. The first-ever oral therapy, Nexletol has been recommended for treating patients with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) requiring additional lowering of LDL-C. 

Other anti-cholesterol therapies such as Praluent and Repatha, which are administered intravenously, Nexletol will have the upper hand in terms of convenient administration route. Moreover, Esperion’s drug will cost comparatively lesser than the other available in the market and will be rolled in the market in March. 

The company is also hoping for positive results for its another LDL-C lowering medicine – bempedoic acid and ezetimibe combination tablet – known for reducing low-density lipoprotein cholesterol and cholesterol absorption respectively.

Karius – a California-based start-up – focused on liquid biopsy tests – has raised USD 165 Million in Series B round.

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

Liquid biopsies have been gaining steam past years as they can easily detect foreign-derived biomarkers, genetic materials in body fluids – blood and urine, helping in detection of tumors, prenatal screening and others. The company, in the same way, is making tools to detect pathogens applying DNA sequencing and machine learning techniques.