French drug maker Sanofi (SNYNF,SNY) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion for an additional indication for Plavix (clopidogrel) in adult patients with high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS).
The company noted that the new indication includes Plavix used alongside aspirin within 24 hours of an event and continued for 21 days, followed by long-term single anti-platelet therapy.
Following this CHMP positive opinion, Sanofi expects a final decision about the new, expanded indication in the first quarter of 2021.
The additional indication is based on the results of two double-blind, randomized, placebo-controlled investigator-initiated Phase 3 trials involving more than 10,000 patients.
The results of the two trials showed that the combination of Plavix and aspirin initiated within 24 hours is superior to aspirin alone for reducing the risk of subsequent stroke, with an overall acceptable safety profile.
In an international population, the POINT study tested the combination of Plavix and aspirin on 4,881 patients. The study found that 25 percent fewer people suffered major ischemic events after treatment with Plavix and aspirin compared with treatment with aspirin alone.
In the CHANCE study, which randomized 5,170 patients in China after an initial minor IS or high-risk TIA event, 32 percent fewer people treated with Plavix and aspirin suffered subsequent strokes compared with those treated with aspirin alone.
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