GSK’s Promacta extends US licence
pharmafile | November 22, 2012 | News story | Sales and Marketing | FDA, GSK, Promacta, Revolade
GlaxoSmithKline’s Promacta has received a new indication from the FDA which means it can be used for patients with thrombocytopenia (reduced blood platelet count) who have chronic hepatitis C.
It is the first supportive care treatment approved for this patient group, and the idea is that it will allow interferon-based therapy to start and be maintained.
Patients with low platelet counts are often ineligible or poor candidates for interferon, because such therapies can actually worsen the problem.
But GSK says Promacta (eltrombopag) plus treatment with interferon has been shown to improve a patient’s chance of achieving a sustained virologic response or viral cure.
Promacta, which carries the brand name Revolade outside the US, was first authorised as an oral treatment for patients with chronic immune thrombocytopenic purpura (ITP) in 2008.
It is indicated for ITP patients who have not responded to other treatments, such as corticosteroids and immunoglobulins. Discovered as part of a research collaboration between GSK and biotech company Ligland Pharma, it gained European approval in this indication in 2010.
The US regulator extends its reach, and means more chronic hepatitis C patients may be able to start and stay on interferon-based therapy.
Paolo Paoletti, president of GSK Oncology, said: “That gives these patients a better chance to achieve a viral cure.”
The ENABLE 1 and 2 trials looked at Promacta in 1,521 patients with platelet counts <75,000/µL. ENABLE 1 used peginterferon alfa-2a (Roche’s Pegasys) plus ribavirin for antiviral treatment, and ENABLE 2 used peginterferon alfa-2b (Merck’s PegIntron) plus ribavirin.
Promacta should not be used in an attempt to bring platelet counts up to the required levels – and its safety and efficacy have also not been established in combination with direct-acting antiviral agents used to treat chronic hepatitis C genotype 1 infection.
Adam Hill
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