Novartis and Amgen drugs signed-off by European Commission
pharmafile | November 24, 2015 | News story | Manufacturing and Production | Amgen, Entresto, European Commission, Novartis, blincyto
The European governing body, the European Commission, has approved the Novartis drug Entresto for heart failure and Amgen’s Blincyto for acute lymphoblastic leukaemia.
Novartis’s Entresto (sacubitril/valsartan) is now approved as a treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Amgen’s Blincyto (blinatumomab) is available for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
The Novartis decision comes shortly after the European Commission also approved Novartis’s psoriasis drug, Cosentyx (secukinumab), for the treatment of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA).
Entresto was recommended by the European Medicines Agency in September, and was available in England via the MHRA’s Early Access to Medicines Scheme. No new patients will be able to receive treatment with Entresto now that it is approved by the EC. However Novartis says it is currently preparing for the drug to be available in the UK before the end of 2015.
“Heart failure is a potentially life-threatening condition that has a major impact on patients and their carers,” says Dimitrios Georgiopoulos, who is chief scientific officer at Novartis Pharmaceuticals UK. “There is a real need for new and effective treatments that reduce mortality and morbidity while improving patients’ quality of life. Sacubitril/valsartan is a new first-in-class treatment option for heart failure patients with reduced ejection fraction that demonstrated a significant mortality benefit, including reducing the risk of sudden death versus, the current standard of care.”
Amgen was granted orphan drug designation for Blincyto by the EMA in 2009. The EC approval is a conditional license, which must be renewed every year and it will be converted to full standard license once post-licensing commitments have been fulfilled. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
ALL is a rare and rapidly progressing cancer of the blood and bone marrow. For adults with relapsed or refractory ALL, the median overall survival is just three to five months, and around 900 people in Europe are diagnosed with Ph-relapsed or refractory B-precursor every year.
“We are pleased the European Commission granted conditional marketing authorization for Blincyto,” says Sean Harper, executive vice president of research and development at Amgen. “Blincyto has demonstrated efficacy in treating relapsed or refractory ALL, a very difficult-to-treat disease for which historically patients had limited therapeutic options. This approval represents an important milestone in immunotherapy research. Blincyto is the first clinical validation of the BiTE platform, a new and innovative approach that helps the body’s own immune system fight cancer.”
Lilian Anekwe
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