Image source: AstraZeneca

After a long and winding road, the FDA given its nod of approval to AstraZeneca’s antiplatelet ticagrelor (Brilinta), indicated to prevent atherothrombotic events in patients with acute coronary syndromes (ACS). The agency had held off of making a decision on the drug with a request for the company to conduct an additional analysis of study data surrounding the drug.

The FDA delayed making a decision on ticagrelor twice this past year. The drug and its maker have faced increased scrutiny and have been awaiting a decision on ticagrelor after the FDA issued a complete response letter to the London-based AstraZeneca requesting additional analyses of the PLATO trial for the new drug application (NDA).

In February, the FDA acknowledged that it had received AstraZeneca’s reply to the complete response letter issued by the agency for the NDA of ticagrelor and categorized the drug as a Class II resubmission to the complete response letter.

The FDA’s decision is supported by the results of the PLATO (PLATelet inhibition and patient Outcomes) trial that evaluated almost 19,000 patients and found that ticagrelor decreased incidences of cardiovascular death, MI and stroke when compared to Bristol-Myers Squibb’s and Sanofi-Aventis’ widely prescribed clopidogrel (Plavix).

“Brilinta represents a significant advancement in the treatment of patients with acute coronary syndromes, especially for the approximately 30 percent of patients who may not respond [to] Plavix,” PLATO investigator Paul Gurbel, MD, director of the Sinai Center for Thrombosis Research, told Cardiovascular Business. “Additionally, the rapid onset of the drug provides a distinct advantage in the treatment of high risk patients and Brilinta’s reversible binding may provide critical flexibility for patients who may require surgery.”

However, the FDA said that the company will add a boxed warning to the drug's label outlining that a maintenance dose of aspirin above 100 mg may decrease the effectiveness of the drug and should be avoided.

Brilinta was approved with a Risk Evaluation and Mitigation Strategy, to ensure that ticagrelor's benefits outweigh the risks, according to the FDA. Additionally, the company must conduct educational outreach to physicians to alert them about the use of higher doses of aspirin (above 100 mg) with the drug.

The drug recently approved in Canada, has also been approved in the European Union under the trade name Brilique. The drug is pending regulatory review in 45 countries.