When last we visited clinical trial results for the drug, it was called INCB18424, but the addition of a chemical name didn't change much. The drug still produced positive results.
In the new trial, ruxolitinib reduced the size of the spleens in patients with myelofibrosis, a type of blood cancer. The companies didn't give details beyond the fact that there was a statistically significant difference.
In the first trial, the difference was extraordinarily large with 42% of patients seeing at least a 35% reduction in their spleen size compared to less than 1% of patients taking placebo.
The exact number for the second trial isn't particularly important for the companies to get the drug on the market in the U.S. and EU; meeting the primary endpoint in two trials will be more than sufficient. Since it's a cancer drug without any good treatment, safety isn't likely to be a major concern.
But the level of efficacy could be important in the future with a multitude of drugs trailing behind. YM BioSciences'
Incyte and Novartis' best bet is to stay one step ahead of the competition by finding other indications where ruxolitinib might work. The drug inhibits JAK1 and JAK2, which are involved in stimulating blood cell production. Mutations in the genes are present in other blood cell diseases including polycythemia vera and essential thrombocytopenia, which could help grow sales of ruxolitinib.
But first, look for one more additional name. Incyte is planning on submitting a marketing application in the second quarter, which could have the drug on the market by the end of the year, at which point it'll need a brand name.
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