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Two Novartis drugs get first in class EU approvals

pharmafile | September 2, 2015 | News story | Research and Development, Sales and Marketing Novartis 

The European Commission has approved Revolade for severe aplastic anaemia, and the combination of Tafinlar and Mekinist for patients with an aggressive form of melanoma. 

Revolade (eltrombopag) is the first therapy approved in the EU for adults with severe aplastic anaemia (SAA) who failed to respond to standard treatments. The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) is the first targeted therapy combination approved in the EU to treat adults with the most aggressive form of skin cancer, unresectable or metastatic melanoma with a BRAF V600 mutation. 

Revolade was originally produced by GSK, and was acquired by Novartis as part of its $16 billion purchase of GSK’s oncology portfolio last year, as part of an asset-swap agreement.

Its approval gives people with SAA who were either refractory to prior immunosuppressive therapy or heavily pre-treated and unsuitable for hematopoietic stem cell transplant, another treatment option for the rare blood disorder, in which the bone marrow does not make enough red and white blood cells or platelets. Two in every one million people in Europe are diagnosed with aplastic anaemia every year. 

The European Commission approved Revolade based on the results of a pivotal open-label Phase II study and two supporting Phase II studies conducted by the National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). 

Alessandro Riva, global head, Novartis Oncology development and medical sffairs, welcomed the Commission’s approval, saying: “[It] is important news for adults in the EU with severe aplastic anaemia, who now have an alternative to standard therapies that have not provided sufficient benefit,” Revolade helps address an unmet need in this community and underscores our commitment to patients affected by rare diseases.” 

While the skin cancer combination approval is based on results from the Phase III COMBI-d and COMBI-v studies, in which the Tafinlar/Mekinist combination demonstrated overall survival benefit compared to Tafinlar and Roche’s Zelboraf (vemurafenib) alone. 

“We look forward to making the Tafinlar and Mekinist targeted combination treatment, which demonstrated a significant overall survival benefit in two robust clinical trials, available across Europe as soon as possible,” said Bruno Strigini, president of Novartis Oncology. “Today’s EU approval further demonstrates our ongoing commitment to deliver medicines that can further enhance outcomes for patients with metastatic melanoma.” 

Joel Levy 

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