AZ and BMS diabetes drug needs more data
pharmafile | January 20, 2012 | News story | Research and Development, Sales and Marketing | AstraZeneca, BMS, FDA approvals, diabetes
AstraZeneca and Bristol-Myers Squibb must supply more data on their diabetes treatment dapagliflozin, the FDA says.
Currently being developed as monotherapy, in addition to diet and exercise, the drug has been held up due to safety concerns.
The FDA set out its requirements in a ‘complete response letter’, saying more data was needed from ongoing clinical trials and – in a move that could give the firms their biggest headache – says it may also want information from new ones.
AstraZeneca and BMS insist they “will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures”.
Last July the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee rejected the compound, throwing its future into doubt.
The committee’s main worry was over instances of breast and bladder cancer in patients, raising the possibility of further trials being needed, which could greatly delay – or even halt – the drug’s progress.
The committee made its decision after reviewing data involving 4,200 patients in studies designed to evaluate dapagliflozin’s safety, tolerability and efficacy as measured by blood sugar levels (HbA1c).
Both companies say they remain “committed to dapagliflozin and its development”, and its potential is significant: it could be the first in a new class of insulin-independent, oral type II diabetes drugs.
They also point to a clinical development programme in which more than 5,000 patients were treated with dapagliflozin in 19 trials.
The drug uses a sodium-glucose cotransporter-2 (SGLT2) inhibitor, which acts independently of insulin mechanisms and facilitates the excretion of glucose and associated calories in the urine, thereby lowering blood glucose levels.
It is also being tested in combination with other diabetes agents, in addition to diet and exercise, to evaluate its effect on HbA1c.
In 2010 the drug showed a strong performance in a late-stage diabetes trial when tested as a second-line treatment with existing diabetes treatments and compared with Pfizer’s Glucotrol.
Patients taking dapagliflozin plus metformin achieved an identical adjusted mean reduction in HbA1c compared with those taking Glucotrol plus metformin.
Numbers of hypoglycaemic events were far lower for patients treated with dapagliflozin plus metformin versus those treated with Glucotrol plus metformin (3.5% vs. 40.8%), and they saw significant weight loss.
Adam Hill
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