FDA approval of first-in-class Aimovig set to transform the migraine market

FDA approval of first-in-class Aimovig set to transform the migraine market
by
Senior Editor (Forecast Team) at Clarivate Analytics
FDA approval of first-in-class Aimovig set to transform the migraine market
Ulrike Jahnke
Senior Editor (Forecast Team) at Clarivate Analytics
Ulrike Jahnke is a senior editor on the Cortellis Forecast team. She has more than 10 years of experience in the pharmaceutical industry, drafting critical reviews about the competitive pharmaceutical landscape, writing news alerts, SWOT analyses, conference reports, market insights and feature articles. Ulrike has a PhD in Oncology and a 1st Class Honours degree in Biochemistry.
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This article is part of an ongoing blog series profiling the12 new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for the latest updates.

Approval of Amgen and Novartis’s potential blockbuster Aimovig (erenumab), a first-in-class calcitonin gene-related peptide (CGRP) receptor inhibitor for migraine prevention, was predicted in the 2018 Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. As expected, the FDA approved Aimovig on the PDUFA date of May 17, 2018, and the drug was scheduled to be launched within one week. After little movement in the migraine prevention market for many years, Aimovig signals the beginning of a new era of treatment for migraine sufferers. EU approval is expected in the coming months.1

“After little movement in the migraine prevention market for many years, Aimovig signals the beginning of a new era of treatment for migraine sufferers.”

Migraine is characterized by recurrent headaches that cause moderate to severe pain, among other symptoms. The disorder is the third most common in the world with an estimated global prevalence of 14.7%. Migraine is responsible for 2.9% of all years of life lost to disability and is the leading cause of disability among all neurological disorders. Furthermore, fewer than 50% of patients with migraine are satisfied with their current treatment.2,3

CGRP plays an important role in migraine, and Aimovig is a monoclonal antibody that acts by blocking the CGRP receptor; the drug is differentiated from other candidates in development as it targets the CGRP receptor rather than the CGRP molecule itself. In the STRIVE trial for the prevention of episodic migraine which supported approval, a significant 3.7-day reduction in monthly migraine days versus 1.8 days for placebo was achieved, and subsequent data showed that effects on monthly migraine days were sustained for up to 15 months.1,4  According to recently reported results from the LIBERTY trial, the first dedicated trial in difficult-to-treat patients with episodic migraine who have failed two to four prior treatments, patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by at least 50% compared with placebo.5

“…Patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by at least 50% compared with placebo.”

The most common adverse events of Aimovig are injection-site reactions and constipation. With a discontinuation rate of 2% due to adverse events, the majority of patients are able to start and stay on therapy. Aimovig is self-administered once-a month with the SureClick autoinjector, similar to an insulin pen, thus making it a convenient treatment option.1

At the time of writing the Drugs to Watch report, Aimovig Cortellis Consensus Forecast data (source Thomson Reuters I/B/E/S) projected sales for 2022 of $1.170 billion, but the forecast has now risen to $1.426 billion. However, prior to achieving blockbuster status, Aimovig faces several hurdles, including payer negotiations and imminent competitors.

Figure 1. At the time of writing the Drugs to Watch report, Aimovig Cortellis Consensus Forecast data (source Thomson Reuters I/B/E/S) projected sales for 2022 of $1.170 billion, but the forecast has now risen to $1.426 billion.

After payers had already raised concerns over high pricing for this new class of drugs, Amgen and Novartis set the U.S. list price of Aimovig at $6,900 annually. This price is lower than the analyst-anticipated price tag of $10,000, potentially helping to quickly capture a big share of the market before competition enters the market.1,6 Several rival drugs targeting CGRP are close behind, with Eli Lilly’s galcanezumab and Teva’s fremanezumab the closest potential competitors.7,8 With approval and launch for both expected later in 2018, Aimovig needs to make the most of its first-to-market advantage, and as of now, Aimovig is set to reap the greatest benefit, with 2022 forecasts of galcanezumab and fremanezumab forecast much lower than Aimovig at $630 million and $960 million, respectively.

Read the full 2018 Drugs to Watch report here, or follow this series for latest updates.

References

  1. https://www.prnewswire.com/news-releases/novartis-and-amgen-announce-fda-approval-of-aimovig-erenumab-aooe-a-novel-treatment-developed-specifically-for-migraine-prevention-300650779.html
  2. http://www.who.int/mediacentre/factsheets/fs277/en/
  3. http://www.migrainetrust.org/wp-content/uploads/2015/12/2010Mar-APPGPHD_REPORT_Headache_Disorders-NotRespNotReso.pdf
  4. http://jnnp.bmj.com/content/88/5/e1.62
  5. https://www.prnewswire.com/news-releases/amgen-reports-aimovig-erenumab-met-all-primary-and-secondary-endpoints-in-unique-phase-3b-study-in-episodic-migraine-patients-who-have-failed-multiple-prior-preventive-treatments-300586199.html
  6. https://firstwordpharma.com/node/1559410
  7. https://www.businesswire.com/news/home/20180503005663/en/Teva-Reports-Quarter-2018-Financial-Results
  8. https://www.prnewswire.com/news-releases/lillys-galcanezumab-meets-primary-endpoint-in-phase-3-study-evaluating-galcanezumab-for-the-prevention-of-episodic-cluster-headache-300648022.html

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