Head-to-head trial favours Shire’s Fosrenol
pharmafile | October 8, 2009 | News story | Research and Development, Sales and Marketing |Â Â fosrenol, renalÂ
Shire's Fosrenol could have a clinical advantage over rival drug Renagel from Genzyme, according to the results of what is thought to be the first head-to-head study looking at their efficacy in dialysis patients.
Both drugs are designed to prevent excessive levels of phosphate building up in the blood of patients with chronic kidney disease on haemodialysis, and have been big earners for the companies.
Published in the journal Clinical Nephrology, the 12-week study randomised 182 patients to receive either treatment with Fosrenol (lanthanum carbonate) or Renagel (sevelamer hydrochloride) for four weeks, with each group crossing over to the other drug for a further four weeks after a washout period.
The study found a statistically significant advantage for Fosrenol over Renagel in lowering serum phosphate among 119 patients that completed both courses of therapy, with Shire's drug achieving a 1.8mg/dL reduction compared to 1.3mg/dL for the Genzyme treatment (p=0.0113).
Fosrenol also performed significantly better one week into treatment, but there was no significant difference between the two therapies if the entire study population – including drop-outs – was assessed.
The lead investigator in the study, Prof. Stuart Sprague of Northwestern University Feinberg School of Medicine in Chicago, said the study was important because "until now, there was no data comparing the relative efficacies of lanthanum carbonate and sevelamer".
However, given the failure to show a significant difference overall, Sprague cautioned that further research is needed to see "whether the trends observed in this crossover study are continued in the long-term".
Renagel (sevelamer HCl) – along with recently-launched follow-up Renvela (sevelamer carbonate) which has been shown to improve bicarbonate levels compared to its parent – is the market leader in the non-calcium phosphate binder category.
Combined sales of the two products were nearly $350 million in the first half of the year, although sales growth has started to slow in recent quarters in the face of competition from other products and a shift towards prescribing of older cheaper products, particularly in the US. The sevelamer portfolio currently accounts for around 14% of group product sales.
Meanwhile, Fosrenol (lanthanum carbonate) brought in $90 million for Shire in the same period, a rise of 14% year-on-year, and it now accounts for about 7% of total product sales.
The total market for phosphate binders, including older calcium and aluminium-based products that have been falling out of favour because of side effects, is estimated at around $750 million a year at present and could top $1 billion on the back of rising prevalence of end-stage kidney disease among people with diabetes and hypertension.
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