CHMP issues positive opinions for AstraZeneca’s three marketing applications

The committee recommended approval for the company’s lesinurad 200 mg tablets, in combination with a xanthine oxidase inhibitor (XOI), for the adjunctive treatment of of hyperuricaemia in adults with gout (with or without tophi) who have failed to achieve target serum uric acid levels with a XOI alone.

Lesinurad inhibits the urate transporter, URAT1, which is responsible for the most of the renal reabsorption of uric acid. If approved, it will be the first selective uric acid reabsorption inhibitor in the European Union (EU).

AstraZeneca’s Tagrisso (osimertinib) 80 mg once-daily tablets have also been recommended for approval to treat adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

The company is comparing osimertinib with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III study in patients with EGFR T790M-positive, locally advanced, or metastatic NSCLC who have progressed after EGFR-TKI therapy.

The company’s Brilique (ticagrelor) 60 mg has also received positive opinion to treat patients with a history of heart attack who are at high risk of a further atherothrombotic event.

Brilique 90mg is currently approved in the EU to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome.

Image: AstraZeneca Headquarters, London. Photo: courtesy of AstraZeneca.