Takeda and AMAG Pharmaceuticals have won approval in the EU for Rienso, an intravenous therapy for iron deficiency anaemia in patients with chronic kidney disease (CDK), and say they will launch it later this year.
The companies carried out three phase III trials to support approval of Rienso (ferumoxytol), which showed that the drug significantly increased haemoglobin levels as compared to oral iron across the spectrum of CKD patients.
Rienso was well tolerated and had a similar overall treatment-related adverse event rate to oral iron, according to Takeda. Rienso has low levels of free iron compared to other iron formulations, which reduces its propensity to cause side effects and allow it to be administered very rapidly.
Massachusetts, US-based AMAG said the EU approval will trigger a $15m milestone payment from Takeda, with another $15m due on the first commercial sale of Rienso in Europe. Takeda has marketing rights to the drug outside the US.
Rienso is already on the market in the US, where it is sold as Feraheme, and has been approved in Canada. Initially tipped as a potential blockbuster - mainly because unlike most of its competitors Rienso is indicated for use in the non-dialysis setting - sales growth has been relatively slow.
AMAG reported sales of $13.6m in the US in the first quarter of this year, against full-year 2011 sales of $52.1m. The slower-than-expected growth trajectory for Feraheme prompted a restructuring at AMAG last November "to align its operating expenses with projected Feraheme revenues", including a workforce reduction of 25 per cent.
AMAG's chief executive, William Heiden, pointed out that the company has "four significant organic growth opportunities for ferumoxytol". These comprise continued share gains in the US market, international launches and market penetration, label expansion in the US and abroad, and the overall growth of the intravenous iron market.
On a global basis, Rienso's competitors include Vifor's Venofor (iron sucrose) - which currently leads the market - as well as Sanofi's Ferrlecit (sodium ferric gluconate), Watson Pharma's Infed (iron dextran) and American Regent's Dexferrum (ferric oxyhydroxide).