Revolade eltrombopag regulatory update

The U.K.'s NICE issued an updated preliminary appraisal recommending the use of Revolade eltrombopag from GlaxoSmithKline to treat chronic idiopathic thrombocytopenia purpura (ITP) in adults who have had a splenectomy and whose condition is refractory to other treatments or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated. The updated draft includes additional limits to the first preliminary appraisal, which NICE issued last December (see BioCentury, Dec. 24, 2012). Specifically, the updated draft recommends Revolade only in patients whose condition is refractory to standard active treatments and rescue therapies or who have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies. In line with the December draft, the recommendation is contingent on GSK providing Revolade at an undisclosed discount under a patient access scheme. Comments are due April 15, with a second appraisal committee meeting scheduled for April 23. ...