EMA Advisory Committee Recommends Two AstraZeneca DrugsBy
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the marketing authorization of two drugs by AstraZeneca.
The first recommendation is for Tagrisso (osimertinib) 80-mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). This indication includes NSCLC patients whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and patients with a T790M mutation who have not been treated with an EGFR-TKI. Osimertinib is an EGFR-TKI designed to inhibit both the activating, sensitizing mutation (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Nearly two-thirds of patients with EGFRm NSCLC whose disease progresses after EGFR-TKI treatment develop the T790M resistance mutation, for which treatment options are limited.
The positive CHMP recommendation has been received through the EMA's Accelerated Assessment and follows the recent accelerated approval of osimertinib by the US Food and Drug Administration (FDA). In Japan, osimertinib was granted priority review by the Pharmaceuticals and Medical Devices Agency (PMDA). Interactions with regulatory authorities in the rest of the world are ongoing.
The EMA’s CHMP also recommended approval for Brilique (ticagrelor) 60-mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti-platelet therapy.
Brilique 90 mg is currently approved in the European Union to reduce the rate of cardiovascular death, myocardial infarction (also known as heart attack) and stroke in patients with acute coronary syndrome.
The CHMP's positive opinion on Brilique will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein. If approved, Brilique will be the first oral antiplatelet approved in these markets for the long-term treatment of patients with a history of heart attack, according to AstraZeneca.
Brilinta (ticagrelor) 60 mg was approved by the US Food and Drug Administration, to be used in patients with a history of heart attack beyond the first year in September 2015.
Source: AstraZeneca (Tagrisso) and AstraZeneca (Brilique)