Johnson & Johnson and Pharmacyclics Inc. won FDA approval for their breakthrough therapy, Imbruvica, for treatment of a rare blood cancer.
Imbruvica is the second drug to receive FDA approval via the Breakthrough Therapy Designation pathway. Breakthrough status is granted to expedite the development of drugs for life-threatening conditions when preliminary evidence indicates a drug may offer substantial improvement over current treatment. Imbruvica's approval comes just more than four months after the New Drug Application submission was completed in June 2013.
Imbruvica comes with a pricetag of $91 a pill, requiring four pills taken together once a day. That's $364 a day, $10,900 a month, $130,000 a year -- which puts the drug on the high end of cancer drug treatment in terms of cost.
Robert W. Duggan, chief executive of Pharmacyclics, said the price reflected that “mantle cell is an orphan disease” and that the two companies had spent close to $1 billion to bring Imbruvica to market. The companies are, however, promising to offer financial assistance to patients.