FDA approves Alexion's Soliris for rare pediatric blood disorder and J&J's Remicade for children with UC

The US Food and Drug Administration on Friday approved Alexion Pharmaceuticals’ (Nasdaq: ALXN) Soliris (eculizumab) to treat patients with atypical hemolytic uremic syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

Soliris was approved by the FDA and European regulators in 2007 for the treatment of paroxysmal nocturnal hemoglobinuria, a rare and life-threatening blood disorder that causes the destruction of red blood cells. Alexion reported Solaris sales of $185.7 million in the second quarter of 2011, a year-on-year rise of 48%, and approval of the new indication is expected to result in significant hike in the product’s revenues. Atypical HUS accounts for 5% to 10% of all cases of hemolytic uremic syndrome. The disease disproportionately affects children.

No other approved treatments for aHUS