In part 2 of this interview, the vice president of AstraZeneca’s Cardiovascular and Metabolic Diseases portfolio discusses future trials with ticagrelor and when they anticipate a possible FDA approval.
Naeem Khan, MD
This is the second of a 2-part interview. For part 1 of this interview, click here.
Ticagrelor (Brilinta; AstraZeneca) broke onto the scene in 2011 after being granted FDA approval as a blood thinning agent, and then again in 2015 as an oral 60-mg tablet, expanding its indication for the reduction of cardiovascular event risk in patients with a history of cardiovascular disease. Now in 2020, a newly accepted supplemental new drug application (sNDA) gives the drug another chance to add an indication to its label, this time for the reduction of subsequent stroke in patients who have experienced an acute ischemic stroke (AIS) or transient ischemic attack (TIA).1
Results recently released from the phase 3 THALES trial were the basis of the sNDA decision, which demonstrated that treatment with the drug plus aspirin reduced the rate of the primary composite end point of stroke or death by 17% compared with aspirin alone.2 Naeem Khan, MD, vice president, Cardiovascular and Metabolic Disease, AstraZeneca, is not only excited about these data but is looking forward to future studies with the therapy.
In the second of this 2-part interview with NeurologyLive, Khan provides insight on the future of ticagrelor, including the next steps following the sNDA and what potential real-world trials could be on the horizon.
Naeem Khan, MD: Brilinta as everyone knows was granted priority review for the reduction of subsequent stroke in patients who have had AIS or TIA earlier this month. We anticipate a PDUFA date in the fourth quarter of 2020, so it’s coming soon. We know that patients who have had AIS or TIA are at high risk of experiencing subsequent events, which may be disabling or fatal. The FDA priority review reflects Brilinta’s potential as a much-needed treatment option to reduce the rate of subsequent events in these patients. We look forward to working with the FDA to make Brilinta available to these patients as soon as possible. Mainly because there is this massive unmet need.
The THALES trial completes the clinical trial program. But AstraZeneca are continuing to support numerous investigator-sponsored studies that are going to report data over time. In addition to that, we are continuing to understand the value of Brilinta and what it may bring to the real-world setting. These randomized, controlled trials will better understand how the treatment will equate to real-life. Those are some of the things we can anticipate, with additional results and data expected to be released over the next few years.
I think it’s just the visibility of stroke and understanding it a little better. That goes with getting treatment and getting to the hospital. People just think about disease states and what’s going to happen instead of realizing how important and devastating it is. When you look at emergency services, you see how they’re fast with their face, arms, speech and time. Academically, we have to look at ABCD scores and the modified Rankin Scale (mRS) and make sure people understand it really well. That way they can identify the signs and symptoms quickly so we can address this devastating disease early. Everyone knows once you get it, the sequela of it is devastating. I hope the message gets out quickly and I’m excited about having conversations with the regulatory authorities about the possibilities that Brilinta can hold.
Transcript edited for clarity.
1. Brilinta granted FDA priority review for the reduction of subsequent stroke in patients who had an acute ischemic stroke or transient ischemic attack [news release]. AstraZenica. July 9, 2020. astrazeneca-us.com/content/az-us/media/press-releases/2020/brilinta-granted-fda-priority-review-for-the-reduction-of-subsequent-stroke-in-patients-who-had-an-acute-ischemic-stroke-or-transient-ischemic-attack-07082020.html. Accessed July 9, 2020.
2. BRILINTA significantly reduced the rate of the composite of stroke and death in patients who had an acute ischemic stroke or transient ischemic attack in the phase 3 THALES trial [news release]. Wilmington, DE. AstraZeneca. Published July 16, 2020. Accessed July 16, 2020. astrazeneca-us.com/content/az-us/media/press-releases/2020/brilinta-significantly-reduced-the-rate-of-the-composite-of-stroke-and-death-in-patients-who-had-an-acute-ischemic-stroke-or-transient-ischemic-attack-in-the-phase-iii-thales-trial-07162020.html