Pradaxa (Dabigatran) manufactured by Boehringer Ingelheim is the first new generation anticoagulant approved by the Food and Drug Administration (FDA) this week. The indication is limited to patients with Atrial Fibrillation at this time even though it has been approved for other DVT/PE related indication in other countries.
This is a first in a number of emerging therapies from other manufacturers that are expected to receive FDA approval in the not too distant future related Deep Vein Thrombosis (DVT)-related indications and Atrial Fibrillation. FDA release http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm.
National Blood Clot Alliance (NBCA) President Randy Fenninger said, “Good news, this is an important day in the history of anticoagulation management as the approval of Pradaxa is the first of a new generation of anti-coagulants. The indication is limited to atrial fibrillation and we are eager to learn of new developments. We expect that other indications will be sought for Pradaxa, as well as, the approval of other new generation therapeutics in the future.”
Chair of NBCA Medical and Scientific Advisory Board, Dr. Jack Ansell said that, “The medical community has been looking forward to new anti-coagulants and this is a positive step offering new options for patients with atrial fibrillation. We look forward to additional emerging therapies and expanded indications for DVT & PE.”