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Novartis’ Promacta receives US breakthrough therapy designation

Regulatory filings of the rare blood disorder treatment are expected this year

Novartis

Novartis drug Promacta has won another breakthrough status from the US Food and Drug Administration (FDA), setting up the Swiss pharma firm for a promising start to 2018.

The news comes hot on the heels of FDA breakthrough status for the company’s breast cancer drug Kisqali.

For rare blood disorder drug Promacta (eltrombopag), the status was awarded for its use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anaemia (SAA) as a first-line therapy.

Samit Hirawat, head of Novartis oncology global drug development, said: “Promacta is a promising medicine that, if approved for first-line use in SAA, may redefine the standard of care for patients with this rare and serious bone marrow condition.

“We will continue to work closely with the FDA to make Promacta available to patients with SAA who are new to treatment as soon as possible.”

Known as Revolade in most countries outside the US, Promacta gained its breakthrough therapy designation following positive data, which 52% of treatment-naïve severe aplastic anaemia (SAA) patients achieved complete response with the drug when given with standard immunosuppressive therapy.

The drug, which is the only TPO receptor agonist indicated for SAA in the refractory setting, is already approved as a second-line therapy in the same indication.

Patients are diagnosed with SAA when their bone marrow fails to produce enough red blood cells, white blood cells and platelets and according to Novartis up to one-third of patients do not respond to current therapies of relapse.

Regulatory filings for a first-line indication in the US and Europe are expected to be made for Promacta/Revolade later this year.

Article by
Gemma Jones

5th January 2018

From: Regulatory

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