AstraZeneca Gains Two EU Approvals and FDA Breakthrough Status for Immuno-Oncology Drug Candidate
AstraZeneca reports several updates to its drug pipeline, including two approvals in the European Union (EU) and one breakthrough therapy designation by the US Food and Drug Administration (FDA).
In the first move, the European Commission (EC) approved Brilique, an oral antiplatelet treatment that works by inhibiting platelet activation. Brilique 90 mg is already approved in the EU for the prevention of atherothrombotic events in adults with acute coronary syndrome (ACS). In the management of ACS, the recommended maintenance dose of Brilique is 90 mg twice daily during the first year after an ACS event. Now, after the first year, patients with a history of heart attack can continue to be treated with the lower dose Brilique 6 mg twice daily, which should be taken with a daily maintenance dose of aspirin of 75-150 mg.
In September 2015, Brilinta (ticagrelor) 60 mg was approved by the FDA with patients with a history of heart attack beyond the first year.
Brilique is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilique works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic cardiovascular (CV) events, such as a heart attack or CV death, in patients with ACS.
In other news, the EC has granted marketing authorization for AstraZeneca’s Zurampic (lesinurad) 200 mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.
Zurampic is a selective uric acid reabsorption inhibitor (SURI) that inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, Zurampic increases uric acid excretion and thereby lowers sUA.
The EC marketing authorization applies to all member states of the EU, Iceland, Norway, and Lichtenstein. It follows the approval in December 2015 by the FDAof Zurampic (lesinurad) 200 mg tablets in combination with an XOI for the treatment of hyperuricemia associated with gout in patients who have not achieved target sUA levels with an XOI alone.
Lastly, the FDA granted breakthrough therapy designation for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen. Durvalumab is also being tested in first-line bladder cancer as a monotherapy as well as in combination with tremelimumab as part of the DanubePhase III trial which achieved first patient in during the final quarter of 2015.