Prescription analysis of the new drug Irenaiumab of Novartis

On September 21, 2023, Novartis' Erenumab injection was approved for sale in China, only once a month, for the prevention of partial headache in adults.

Erenumab injection is the world's First fully human monoclonal antibody targeting CGRP receptor, developed by Novartis and Amgen. It works by blocking CGRP receptor molecules involved in the pathophysiological mechanism of partial headache. The benefits of preventive treatment for partial headache have been recognized by a number of international and domestic academic guidelines.

In May 2018, Erenumab was approved by the FDA, becoming the world's First approved antibody drug targeting CGRP receptor. In July 2018, the drug was marketed in the European Union.

According to the company's financial report, Erenumab will have sales revenue of $632 million in 2022.

The prescription information is as follows:

erenumab-aoe is a human immunoglobulin G2 (IgG2) monoclonal antibody with high affinity to calcitonin gene-related peptide receptors. erenumab-aoe was prepared in Chinese hamster ovary (CHO) cells using recombinant DNA technology. It consists of two heavy chains, each containing 456 amino acids, and two light chains of the λ subclass, each containing 216 amino acids, with a molecular weight of about 150kda.

AIMOVIG (erenumab-aoe) injection is sterile, preservative-free, transparent to milky white, colorless to light yellow solution, which is administered subcutaneally in prescript form.

Each 1 mL 70 mg single-dose prefilled autoinjector and 70 mg single-dose prefilled glass syringe contains 70 mg erenumab-aoe, acetic acid (1.5 mg), polysorbate 80 (0.10 mg), and sucrose (73 mg).

Each 1 mL 140 mg single-dose prefilled autoinjector and 140 mg single-dose prefilled glass syringe contained 140 mg erenumab-aoe, acetic acid (2.0 mg), polysorbate 80 (0.10 mg), and sucrose (65 mg). The pH of the solution is 5.2.

In addition to Novartis, the global CGRP (calcitonin gene-related peptide) targeting headache drugs that have applied for listing in China include Pfizer's Rimegepant and Eli Lilly's Galcanezumab, and are also expected to be approved in China this year.

Since its establishment nearly 20 years ago, Aivito has always focused on high-end injection grade excipients, long-term stable supply of injection grade trehalose, sucrose, TRIS/ TRIS-HCL, HEPES and other biologics excipients, with GMP production conditions, Sino-US double report, low internal toxin, DNase& RNase free, In line with the international mainstream pharmacopoeia standards, quick supply and other advantages.

Among them, sucrose (for injection) has passed the associated review, activation is A status (registration number: F20200000093, CDE official website can be found), used in a number of listed injection preparations, stable supply of a number of domestic head pharmaceutical companies. Help the development and production of antibody drugs, liposome drugs, mRNA vaccines and other injection preparations and domestic and foreign declarations!