Novartis Submits IND Application for Aimovig (Erenumab), the Second CGRP Monoclonal Antibody to Enter China’s Regulatory Pipeline

Today (May 20), the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that Novartis has submitted an Investigational New Drug (IND) application for its novel CGRP-targeted therapy, Aimovig (erenumab), with acceptance number JXSL1900048. Notably, this is the second CGRP monoclonal antibody drug to have an IND application submitted in China.

Table 1 CGRP Inhibitors with IND Applications Submitted in China

Aimovig: The First-Approved CGRP Monoclonal Antibody Drug in Its Class

Migraine is a common type of headache that has currently become the third most prevalent disease worldwide, imposing a significant psychological burden on patients and a substantial economic burden on society.

Calcitonin gene-related peptide (CGRP) is a neuropeptide composed of 37 amino acid residues, released from the terminals of primary sensory neurons in the trigeminal ganglion. It has been demonstrated that CGRP levels significantly increase during migraine attacks, playing a role in initiating, modulating, and transmitting migraine signals, as well as enhancing sensitivity.

Currently, CGRP has become the most sought-after target in the development of migraine treatments. David Dodick, a neuroscientist at the Mayo Clinic and President of the International Headache Society, considers CGRP to be the best target discovered to date for combating migraines.

Aimovig is the first drug developed for migraine prevention by targeting and blocking the CGRP receptor. Co-developed by Novartis and Amgen, the two companies are jointly responsible for its commercialization in the US market. Amgen retains exclusive commercialization rights in Japan, while Novartis holds exclusive commercialization rights in Europe, Canada, and other regions. In May 2018, Aimovig was approved for marketing in the United States, becoming the first approved CGRP monoclonal antibody therapy in its class. In addition to Aimovig, two other anti-CGRP therapies have been approved in the United States and the European Union: Eli Lilly’s Emgality (galcanezumab) and Teva’s Ajovy (fremanezumab).

Migraine: Competitive Landscape of CGRP Targets

Currently, there are seven notable CGRP-targeting drugs worldwide. EvaluatePharma predicts that the global CGRP market will reach $5 billion in 2024, with four CGRP antibodies ranking among the top four.

Figure 1. Forecast of CGRP Market Sales Data (in USD billion)

Data source: EvaluatePharma Image source: CPHI Online

Regarding medication administration, both Aimovig and Emgality are administered via subcutaneous injection once monthly, whereas Ajovy can be administered via subcutaneous injection either once monthly (225 mg) or once quarterly (675 mg). Ajovy is currently the first and only anti-CGRP migraine medication that offers the flexibility of both quarterly and monthly dosing regimens.

According to the financial reports of each company, in 2018, the sales revenues for Aimovig, Ajovy, and Emgality were $119 million, $4.9 million, and $3 million, respectively. In the first quarter of 2019, the sales revenues for Aimovig, Ajovy, and Emgality were $59 million, $20 million, and $14.2 million, respectively.

In addition to the three CGRP monoclonal antibody drugs already approved, two other drugs are currently under review. In late February, Alder’s monoclonal antibody drug eptinezumab (administered via intravenous infusion once every three months) was submitted to U.S. regulators for approval, with response rates in certain patients reaching as high as 100%. In early March, Allergan submitted a marketing application in the United States for the oral drug ubrogepant for the acute treatment of migraine (with or without aura), and the FDA is expected to make its final review decision in the fourth quarter. If approved, ubrogepant would become the first oral CGRP receptor antagonist for the acute treatment of migraine (with or without aura) in the U.S. market in 25 years.

Table 2 Seven Notable CGRP-Targeting Drugs Worldwide

EvaluatePharma predicts that from 2018 to 2024, the market share of CGRP will steadily increase, with antibody drugs accounting for the vast majority.