Brilinta's stroke benefit is revealed, but Astra's clock is ticking

After failing to prove that Brilinta was any better than aspirin at preventing a second stroke in the Socrates trial, Astrazeneca combined the two drugs in an attempt to move its blood-thinner into this substantial market. The Thales study succeeded, the company said in January, and today the extent of the benefit was revealed. A significant 17% reduction was detected in a composite endpoint of stroke or death, with a 21% reduction in the risk of a subsequent ischaemic stroke. Adding Brilinta to aspirin comes at a well-known cost, however: significantly more severe bleeding events, including fatal haemorrhages. Measures of disability were not improved; any signal here could have made a big difference to Brilinta’s risk-benefit ratio. The FDA is already reviewing these data under priority review, with a decision due towards the end of the year. A green light would be very useful – the drug’s patent expires in 2024, so Astra needs to wring the most out of Brilinta it can. Sales have long disappointed, and it already seems unlikely that the huge sums invested in label extension studies will ever be recouped (The cost to Astrazeneca of building Brilinta, January 28, 2020).

Building Brilinta: results from Thales in secondary stroke prevention 
  Brilinta + aspirin Aspirin   
  (N=5523) (N=5493) Hazard ratio (p value)
  No of events (%) No of events (%)  
Primary outcome
Stroke or death 303 (5.5) 362 (6.6) 0.83 (0.02)
Secondary outcomes
Ischemic stroke 276 (5.0) 345 (6.3) 0.79 (0.004)
Overall disability* 1282 (23.8) 1284 (24.1) 0.98 (0.61)
Safety outcomes      
Severe bleeding 28 (0.5) 7 (0.1) 3.99 (0.001)
Intracranial hemorrhage or fatal bleeding 22 (0.4) 6 (0.1) 3.66 (0.005)
Premature permanent discontinuation of trial treatment owing to bleeding 152 (2.8) 32 (0.6) 4.80 (<0.001)
*Determined by modified Rankin scale. Source: NEJM.

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