The FDA has handed AstraZeneca a green light to begin marketing dapagliflozin, its long-delayed SGLT2 diabetes drug, which will now try to defy the steadily dwindling expectations of market analysts. The treatment--the first new FDA drug approval for 2014--will be sold as Farxiga.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
Novo Nordisk experienced a nasty setback early this year when the FDA rejected its long-acting insulin Tresiba. But with the diabetes treatment rolling out in other markets, Novo is prepared to confidently bet upwards of $3.7 billion doing the groundwork necessary to develop new oral diabetes therapies and next-gen approaches as it defends its growing franchise for Victoza.
Two years after AstraZeneca and Bristol-Myers Squibb ran into a buzzsaw of regulatory criticism at the FDA for their SGLT2 diabetes drug dapagliflozin, the partners are back with a fresh set of promising Phase III data they hope can help provide the key needed to unlock the U.S. market.
AstraZeneca and Bristol-Myers Squibb are trying once again to get U.S. approval for their drug dapagliflozin, an innovative but potentially risky treatment for Type 2 diabetes.
CHICAGO-- Diabetes partners Boehringer Ingelheim and Eli Lilly's empagliflozin held its own in a slate of Phase III trials, yet the available clinical data make it difficult to show how the experimental treatment stands out from the rest of the SGLT2 bunch.
Jockeying for a leading position in the high-stakes race to develop a new generation of blockbuster diabetes drugs, Merck is hitching a ride with Pfizer's late-stage SGLT2 candidate, ertugliflozin (PF-04971729).
The FDA has approved the first drug in a new class of blood glucose-lowering diabetes drugs: Johnson & Johnson's ($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.
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.
Eli Lilly and its close diabetes drug development partner Boehringer Ingelheim laid out a slate of positive late-stage data for its SGLT-2 treatment empagliflozin this morning, taking a big step toward a new drug application expected later in the year.