GSK submits new Promacta licence
pharmafile | March 3, 2014 | News story | Sales and Marketing | GSK, NICE, Promacta, Revolade, blood, eltrombopag
GlaxoSmithKline is seeking a new licence for its blood disorder drug Promacta in patients with severe aplastic anaemia.
Specifically, the firm has submitted Promacta (eltrombopag) to the FDA for the treatment of cytopenias (a reduction in blood cells) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
SAA is a rare disorder in which the bone marrow fails to make enough new blood cells, and there are currently no approved therapies available for SAA patients unresponsive to IST.
Of those patients unresponsive to initial IST, around 40% die from infection or bleeding within five years of their diagnosis, according to the London-based company.
In February, GSK and development partner Ligand Pharmaceuticals announced that the FDA had granted ‘Breakthrough Therapy’ designation for Promacta in SAA. This will speed-up the review process for the medicine, meaning it could be approved within the next six months.
Its application is based on the results from an open-label, Phase II National Institute of Health study of Promacta in 43 heavily pre-treated SAA patients with an insufficient response to IST.
If approved this new licence would add to its several indications from the FDA, with the most recent being for use in patients with thrombocytopenia (reduced blood platelet count) who have chronic hepatitis C.
The drug, 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.
Revolade in the UK
Revolade has had a turbulent time in the UK after initially being rejected by the cost watchdog NICE in 2010, as its benefits to ITP patients were ‘unclear’ and its cost too high.
It did eventually receive a thumbs up from NICE but not for another three years, and came only after GSK lowered the price of the medicine via a patient access scheme.
In 2012 GSK was found to have breached three clauses of the ABPI Code of Practice following a complaint from a member of its own staff around the off-label promotion of Revolade.
Ben Adams
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