Eptinezumab is under clinical development by H. Lundbeck and currently in Phase III for Cluster Headache Syndrome (Cluster Headache). According to GlobalData, Phase III drugs for Cluster Headache Syndrome (Cluster Headache) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Eptinezumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Eptinezumab overview

Eptinezumab (Vyepti) is a humanized immunoglobulin G1(IgG1) monoclonal antibody, which is produced in Pichia pastoris yeast cells by recombinant DNA technology. It is formulated as solution, concentrate solution for intravenous route of administration. Vyepti is indicated as preventive treatment of migraine in adults.

Eptinezumab is under development for the treatment of episodic cluster headache (eCH), chronic migraine and frequent episodic migraine in EU and Canada. It is administered as an intramuscular, intravenous infusion and subcutaneous injection. The drug candidate is a genetically engineered monoclonal antibody acts by targeting calcitonin gene related peptide(CGRP). It is based on Antibody Selection (ABS) process and Mab Xpress antibody production system. The production system exploits yeast expression system to make fully functional whole antibodies.

H. Lundbeck overview

H. Lundbeck (Lundbeck), a subsidiary of The Lundbeck Foundation, carries out the research, development, manufacturing, and marketing of pharmaceuticals for the treatment of central nervous system (CNS) diseases including psychiatric and neurological disorders. The company’s products are indicated for the treatment of Alzheimer’s disease, migraine, depression, Parkinson’s disease, schizophrenia, alcohol dependence, anxiety, bipolar I disorder, depression, anxiety, psychosis, and epilepsy, among others. It operates production facilities in Denmark, Italy, and France, and research centers in the US and Denmark. Lundbeck sells its products primarily to pharmaceutical distributors, pharmacies, and hospitals in Italy, China, Spain, Canada, France, South Korea, Australia, the US, and other countries. Lundbeck is headquartered in Valby, Denmark.

For a complete picture of Eptinezumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.