By Michelle Fay Cortez and Cristin Flanagan
The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer advocates.
Global Blood Therapeutics Inc., maker of a new sickle cell disease drug called Oxbryta, built a booth to showcase the medicine at the annual meeting of the American Society of Hematology that begins this weekend — even though the Food and Drug Administration’s scheduled approval date was in March.
The move paid off: Oxbryta was given the go-ahead by the FDA on Nov. 25, almost three months ahead of schedule, and the branded booth will make its debut at the ASH conference in Orlando, Florida, on Saturday.
“It’s very much a change,” said Alethia Young, a biotechnology analyst at Cantor Fitzgerald in New York. “It has happened over the past five years, and it’s probably here to stay. In areas of high unmet need, FDA seems to be committed to getting medicines to these people as fast as possible.”
Oxbryta’s approval added to a growing number of breakthrough products that have beaten their FDA deadlines by weeks and sometimes months. For normal…
