Novartis Highlights Long-Term Efficacy of Aimovig in Two Phase III Trials to Strengthen Position in Competitive Migraine Market

Original: Zhixing

On July 1, 2019, Novartis announced the latest data from two Phase III clinical trials of its blockbuster migraine product, Aimovig. The STRIVE trial demonstrated that Aimovig significantly reduced both monthly migraine days (MMD) and monthly days requiring acute migraine medication (MSMD), while the LIBERTY trial confirmed the long-term efficacy of Aimovig in improving patients’ quality of life.

The FDA has approved three anti-CGRP migraine products: Aimovig, Ajovy, and Emgality, all of which were approved in the second half of 2018, causing the migraine market to suddenly become crowded. To maintain its first-mover advantage, Aimovig released the latest data from two Phase III clinical trials, once again demonstrating the therapeutic benefits of Aimovig for migraine treatment, effectively serving as a promotional campaign. This article briefly summarizes the latest clinical developments of Aimovig and compares the three approved anti-CGRP migraine products mentioned above.

Aimovig is a preventive anti-calcitonin gene-related peptide (CGRP) migraine product. CGRP is considered a trigger for migraine attacks and has become a hot target in the development of migraine medications. On May 17, 2018, Aimovig received FDA approval for market launch. To date, more than 220,000 patients worldwide have used Aimovig to prevent migraine attacks, with its sales reaching $59 million in the first quarter of 2019.

On July 1, 2019, Novartis announced the latest results from two Phase III clinical trials, STRIVE and LIBERTY, both demonstrating the significant efficacy of Aimovig in the prevention of migraine.

STRIVE evaluated the safety and efficacy of 70 mg and 140 mg Aimovig for the prevention of episodic migraine in patients who had previously experienced failure with 2–4 other therapies. Recent data indicate that at Week 52 of treatment with 140 mg Aimovig, 55% of patients achieved a greater than 50% reduction in the number of days per month requiring acute migraine medication.

Latest data from LIBERTY show that patients with episodic migraine who had previously failed 2–4 prior preventive treatments demonstrated sustained improvement during weeks 13–24 of treatment with 140 mg Aimovig, further confirming the long-term efficacy of Aimovig, with therapeutic effects not diminishing over time. At week 24, patients exhibited improved physical functioning and enhanced ability to perform daily activities, as reflected by improvements in HIT-6 and MPFID scores.

The unveiling of the latest results from the STRIVE and LIBERTY trials can be seen as a strategic move by Aimovig to compete for market share. Shortly after Aimovig’s approval, Ajovy (fremanezumab) and Emgality (galcanezumab) were successively approved in September 2018. Furthermore, the fourth anti-CGRP product, eptinezumab, submitted its marketing application this February. The previously stable three-way competitive landscape will soon welcome another player, intensifying the competition.

A comparison of the administration routes of three approved migraine products reveals that both Aimovig and Emgality are administered via subcutaneous injection once monthly, whereas Ajovy can be administered via subcutaneous injection either once monthly or once every three months. While Ajovy offers patients greater flexibility in dosing frequency, Emgality provides superior convenience. Eptinezumab, currently under regulatory review, is administered via intravenous infusion once every three months.

Regarding drug pricing and discounts, Aimovig, Ajovy, and Emgality all have a list price of $6,900 per year. On October 17, 2018, Express Scripts (ESI), the largest pharmacy benefit manager in the United States, announced that it would include Aimovig and Emgality on its recommended list of anti-CGRP migraine medications, while excluding Ajovy. This was undoubtedly bad news for Ajovy.

Regarding indications, the initial approved indications for Aimovig, Ajovy, and Emgality were all for migraine prevention. In April 2019, Teva announced that Ajovy failed to meet its primary endpoint in a Phase III clinical trial for the treatment of cluster headache, leading Teva to abandon the cluster headache indication for Ajovy and thereby paving the way for Emgality. On June 4 this year, Emgality secured a new indication for cluster headache, expanding its patient population and gaining a slight competitive advantage in the market.

Emgality is the third migraine product of its class to enter the market, having lost the first-mover advantage. To boost Emgality’s brand awareness, Eli Lilly has invested heavily in television advertising, spending $15.1 million in April and $12.4 million in May.

However, based on sales figures from Q1 2019, Aimovig maintained a significant first-mover advantage, leading by a wide margin with $59 million in sales. Ajovy ranked second with $20 million, followed closely by Emgality with $14 million. Aimovig benefited from its early-launch advantage, while Emgality leveraged expanded indications and aggressive marketing efforts. In comparison, Ajovy’s performance appeared relatively lackluster.

Reference Sources:

1. Novartis data underpin long-term efficacy of Aimovig® where other treatments have failed；

2. Novartis data show Aimovig® cuts acute migraine medication days by half in patients who failed prior preventive therapies。