Novartis’ Promacta bags FDA approval for first-line severe aplastic anemia

Promacta FDA approval : The US Food and Drug Administration (FDA) has approved a label expansion for Novartis’ Promacta (eltrombopag) to cover the treatment of severe aplastic anemia (SAA) in the first-line setting in combination with standard immunosuppressive therapy (IST).

New Promacta FDA approval for first-line severe aplastic anemia

The new Promacta FDA approval is for adults and also for pediatric patients, aged two years and more, who are suffering from severe aplastic anemia.

Sold as Revolade in a majority of countries outside the US, Promacta is an oral thrombopoietin receptor agonist (TPO-RA), which already was approved for severe aplastic anemia for patients who did not show sufficient response to immunosuppressive therapy.

The Novartis drug also has approval to be used in adults and children having chronic immune thrombocytopenia (ITP) who are refractory to other treatments, and for the treatment of thrombocytopenia in patients having chronic hepatitis C virus (HCV) infection.

Novartis reports new Promacta FDA approval for first-line severe aplastic anemia
Novartis reports new Promacta FDA approval for first-line severe aplastic anemia. Photo courtesy of Novartis AG.

Commenting on the new Promacta FDA approval, Liz Barrett – CEO of Novartis Oncology, said: “Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options.

“Today’s US approval for Promacta is an important step forward for people living with this challenging disease and shows how Novartis continues to reimagine care in areas where few treatment options exist.”

The new Promacta FDA approval was driven by the findings of a study that showed 44% of definitive IST-naive SAA patients had registered complete response at six months on treatment with Promacta concurrently with standard immunosuppressive therapy. This was 27% higher than the complete response rate historically noted with treatment with only standard immunosuppressive therapy.

Further, Promacta plus standard immunosuppressive therapy registered an overall response rate of 79% at six months.

Phillip Scheinberg – Head, Division of Hematology, Hospital A Beneficência Portuguesa de São Paulo in Brazil, commenting on the new Promacta FDA approval, said: “Patients with SAA sometimes do not respond to the current treatment standard of IST.

“With this approval, physicians now have an option to add Promacta to the standard IST in a regimen that has demonstrated significant overall and complete response rates upfront in SAA and reduce the numbers of those who are unresponsive to initial therapy.”

In another development, Novartis secured the breakthrough therapy designation from the FDA for Promacta to be used as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome (H-ARS).

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