FDA Grants First Approval to Brilinta Generic

The US Food and Drug Administration (FDA) has approved the first generic medication indicated for lowering the risk of heart attack, or death from heart attack or stroke in patients with acute coronary syndrome (ACS).

Ticagrelor tablets, a generic version of Brilinta from AstraZeneca Pharmaceuticals, have been granted Abbreviated New Drug Application (ANDA) approval in 60 mg and 90 mg doses. According to the FDA, the ANDA applicant company was Watson Laboratories, Inc, a subsidiary of Teva Pharmaceuticals.

Brilinta was first approved by the FDA in September 2015 as an oral 60 mg tablet. As a direct-acting P2Y₁₂ receptor agonist, ticagrelor functions by inhibiting platelet aggregation in patients with ACS or ST elevation.

In the results of the phase 3 PEGASUS-TIMI 54 trial announced in August 2017, twice-daily 60 mg Brilinta was shown to reduce the risk of cardiovascular death in patients by 29% (P = .0041) versus placebo. The patient population were those who had experienced a myocardial infarction or who had stopped adenosine diphosphate antiplatelet therapy with 2 years or 1 year prior to treatment, respectively.

Mikael Dellborg, MD, study steering committee member and a professor of cardiology at the University of Gothenburg, said at the time that the therapy showed clear favorable benefit-risk ratio in patients being treated after the 12-month post-event period.

“This new insight is potentially practice-changing, as while more than seven million people worldwide suffer a heart attack each year, we know that fewer than half receive adequate long-term treatment to reduce their risk of further CV events,” Dellborg said in a statement.

The FDA had announced the decision via its media affairs Twitter account Wednesday morning:

#FDAapproves first generic of a drug that lowers the chance of having another heart attack or dying from a heart attack or stroke in patients with acute coronary syndrome, or ACS. https://t.co/OYwQPsyHwX

— Media Affairs (@FDAMedia) September 5, 2018

The agency did not respond to an MD Magazine® request for comment on the ANDA approval at the time of publication.