AstraZeneca Gets European Approval for Heart Attack, Gout Treatments

Shares of pharmaceutical giant AstraZeneca PLC (NYSE: AZN) ticked down in Friday’s premarket trading in New York after the company announced that the European Commission (EC) had granted marketing authorization for two of its treatments: Zurampic for gout and Brilique for heart attack patients.

Both treatments were approved by the U.S. Food and Drug Administration (FDA) last year.

The EC has granted marketing authorization for Zurampic (lesinurad) 200mg 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 levels with an adequate dose of an XOI alone. As part of the approval, AstraZeneca will conduct a Non-Interventional Post-Authorisation Safety Study (PASS) to investigate the cardiovascular safety profile (mainly in patients with history of cardiovascular disorder) exposed to Zurampic.

Brilique (ticagrelor) was approved at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment may be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti-platelet therapy.
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Earlier this week, AstraZeneca announced that the FDA had granted Breakthrough Therapy designation (BTD) 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 tumor has progressed during or after one standard platinum-based regimen.

The designation is intended to expedite the development of new drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, that demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.

AstraZeneca shares were recently downgraded to Hold from Buy at HSBC, but also raised to Equal Weight from Underweight at Barclays.

Shares of AstraZeneca were down 1.2% at $29.70 in Friday’s premarket, within a 52-week trading range of $28.29 to $36.69.