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FDA seeks more data on BMS and AZ's dapagliflozin for diabetes

Additional clinical trials may also be necessary, with drug linked to increased risk of breast and bladder cancer

The US Food and Drug Administration (FDA) has declined to approve diabetes drug dapagliflozin, developed by Bristol-Myers Squibb (BMS) and AstraZeneca (AZ), saying that it needs additional clinical data to complete its review of the application.

The complete response letter for dapagliflozin requests more clinical data "to allow a better assessment of the benefit-risk profile for dapagliflozin", said the two companies in a statement issued this morning.

The FDA also suggests in the letter that additional clinical trials may be needed to meet its requirements, which could lead to a significant delay for the programme.

The agency had already set back its action date for the review under the Prescription Drug User Fee Act (PDUFA) by three months, after an advisory committee voted narrowly not to recommend approval last July.

One issue debated at the panel meeting was whether the drug might be linked to an increased risk of breast and bladder cancer.

BMS and AZ said that they remain committed to dapagliflozin and will work with the FDA - as well as the authorities in Europe - to determine how to progress the marketing application.

The companies have already committed significant resources to the compound's development, carrying out 19 trials which collectively have enrolled more than 8,000 type 2 diabetes patients.

Dapagliflozin is the first drug in a new class of diabetes drugs, known as sodium-glucose co-transporter 2 inhibitors. SGLT2 is a drug target in the kidney which is thought to play a role in maintaining glucose balance by reabsorbing glucose into the circulation.

One of the positives of the drug is that its mechanism could achieve a small degree of weight loss in type 2 diabetes, unlike other oral medications which tend to cause weight gain.

Analysts have suggested that dapagliflozin could achieve sales of around $650m in 2015 if it reaches the market with a weight-neutral claim.

19th January 2012

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