Few productivity metrics in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.
The FDA has approved the first drug in a new class of blood glucose-lowering diabetes drugs: Johnson & Johnson's ($JNJ) Invokana (canagliflozin) for patients with Type II diabetes. The approval gives the healthcare giant its first market green light for a new diabetes therapy.
The budget cuts required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.
Johnson & Johnson emerged from a showdown with FDA advisers with some scratches but ultimately a win on Thursday. An agency advisory committee backed approval of the company's experimental diabetes drug canagliflozin in a 10-5 vote after reviewers highlighted concerns about increased heart risks in patients on the treatment.
AstraZeneca and Bristol-Myers Squibb were stiff-armed by the FDA on their application for the SGLT2 diabetes drug dapagliflozin, but European regulators believe the benefits outweighed the risks that pushed the agency to reject the innovative therapy early this year.
Johnson & Johnson didn't disappoint close observers of the diabetes drug development field with its battery of late-stage results for the experimental diabetes drug canagliflozin.
Determined to build its stake in the fast-growing diabetes market, Johnson & Johnson plans to showcase late-stage data this weekend on its promising SGLT2 drug candidate that has drawn both praise and skepticism from clinicians and analysts.