The US FDA’s run of ‘breakthrough’ designations for innovative new products continues with newly-awarded expedited reviews for medicines from Amgen and Boehringer Ingelheim.
Amgen received the designation for its cancer antibody blinatumomab for use in the treatment of adults with a specific form of acute lymphoblastic leukaemia (ALL), while Boehringer’s is for an antidote to its anticoagulant Pradaxa (dabigatran etexilate).
The FDA introduced its breakthrough status designation in 2012 to speed up the review process for important new drugs in serious or life threatening conditions that have shown substantial improvements over existing options during clinical trials.
Blinatumomab qualifies as it has demonstrated positive results in Philadelphia-negative (Ph-) relapsed/refractory B-precursor ALL – a cancer of the blood and bone marrow for which there are few treatment options.
The drug is part a new class of immunotherapy called bi-specific T cell engagers or BiTE antibodies, which direct T cells to kill cancer cells.
Boehringer’s breakthrough status is for idarucizumab, which acts as an antidote to its blood clot treatment Pradaxa.
Pradaxa is one of several important new oral anticoagulants to hit the market in recent years that can provide more convenient alternatives to traditional treatments warfarin and heparin.
However, unlike these older therapies, there are no antidotes to reverse their effects when patients develop severe bleeds.
Boehringer is developing idarucizumab to address this issue, potentially giving it the edge over its rivals – such as Bayer/Janssen’s Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban).
The drug has already shown its effect in early trials and is now being studied in the global REVERSE-AD study to test its use in the clinical setting in patients taking Pradaxa.