The Origin and Tumultuous History of Brodalumab
Brodalumab is a biologic medication that functions as a human monoclonal antibody, specifically by blocking the interleukin-17 (IL-17) receptor. This mechanism helps to reduce inflammation, making it an effective treatment for moderate-to-severe plaque psoriasis. The development and commercialization of brodalumab involved several corporate changes and agreements.
Initially developed by Amgen as AMG 827, brodalumab's development advanced through a co-development and commercialization agreement with AstraZeneca starting in 2012. Phase III clinical trials showed positive results for treating plaque psoriasis. However, Amgen decided to terminate its involvement in the program in May 2015, following reports of suicidal ideation and behavior in clinical trials. Although a direct causal link wasn't established, this led AstraZeneca to seek new partners for commercialization, except for certain Asian territories where Kyowa Hakko Kirin (now Kyowa Kirin) held separate rights. The current manufacturing and marketing of brodalumab are divided among several companies based on regional licensing agreements established after Amgen's withdrawal. AstraZeneca partnered with Valeant Pharmaceuticals (now Bausch Health) for the U.S. and Canada rights. In Europe, LEO Pharma acquired the rights from AstraZeneca. Kyowa Kirin obtained rights for Japan and other Asian territories from Amgen early on and maintained them.
Comparison of Brodalumab Commercialization
| Feature | United States & Canada | Europe | Japan & Other Asian Countries |
|---|---|---|---|
| Current Manufacturer | Bausch Health (via Valeant) | LEO Pharma | Kyowa Kirin |
| Brand Name | Siliq™ | Kyntheum™ | Lumicef™ |
| Approval Year | 2017 | 2017 | 2016 |
| Initial Originator | Amgen (with AstraZeneca) | Amgen (with AstraZeneca) | Amgen |
| Noteworthy Aspect | FDA boxed warning, REMS program | Acquired rights from AstraZeneca | Continuous development under Kyowa Kirin |
The Role of Safety Concerns in Shaping Brodalumab's Path
The reported cases of suicidal ideation during clinical trials significantly impacted brodalumab's development and commercialization. Although a definitive causal link was not established, these concerns led to Amgen's withdrawal and influenced the regulatory pathways and marketing strategies for the drug. The FDA's requirement for a REMS program in the U.S., including certified prescribers and informed consent, reflects these initial safety concerns. Despite this, real-world data and pharmacovigilance studies have not revealed new safety signals related to suicidality.
Conclusion
Brodalumab's manufacturing and commercialization are divided among different companies globally due to a series of events, including its initial development by Amgen, the company's withdrawal over safety concerns, and subsequent regional licensing agreements by AstraZeneca. As a result, Bausch Health is responsible for Siliq in the U.S. and Canada, LEO Pharma markets Kyntheum in Europe, and Kyowa Kirin sells Lumicef in Japan and certain other Asian countries. This demonstrates how safety considerations and strategic business decisions can lead to a single medication being managed by multiple entities worldwide.
For additional information regarding the regulatory details and market history of brodalumab, the official FDA approval documents for Siliq, as referenced in the Drugs.com entry, serve as a valuable resource.
