Future of AZ-BMS diabetes drug in doubt
pharmafile | July 20, 2011 | News story | Research and Development, Sales and Marketing | AstraZeneca, BMS, dapagliflozin, diabetes, research and development news
A US advisory committee has rejected an investigational compound for type II diabetes sufferers, throwing its future into doubt.
Dapagliflozin, developed by AstraZeneca and Bristol-Myers Squibb, was given the thumbs down by nine votes to six during a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
The primary concern 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.
“Should the FDA require a study to rule out the risk of cancer, the size of such a study would need to be substantial, and may be a difficult undertaking for Bristol-Myers/AstraZeneca to justify,” said analyst Jeffrey Holford at Jefferies & Company.
The FDA does not have to follow its committees’ recommendations when considering New Drug Applications, but it is a serious setback for the drug, which is being developed as a monotherapy in addition to diet and exercise.
Both manufacturers say they remain committed to dapagliflozin’s clinical development programme and will “continue to work closely with the FDA to support the review”. It is expected that the regulator will send a Complete Response Letter, outlining steps that would need to be taken before it will grant approval, by the end of October.
Dapagliflozin has the potential to be the first in a new class of insulin-independent, oral type II diabetes drugs.
It 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.
The vote was in response to the question: “Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus?”
The drug is also being tested in combination with other anti-diabetic agents in addition to diet and exercise, to evaluate its effect on blood sugar levels (HbA1c) in adults with type II diabetes
The committee voted after reviewing data involving 4,200 patients from 40 clinical studies designed to evaluate the safety, tolerability and efficacy – as measured by HbA1c – of dapagliflozin.
Last year the drug showed a strong performance in a late-stage diabetes trial when tested as a second-line treatment with existing anti-diabetic treatments and compared with Pfizer’s oral anti-diabetic 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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