AstraZeneca (AZ) and Bristol-Myers Squibb (BMS) have made another attempt to win approval for their diabetes drug Forxiga in the US, 18 months after being knocked back.
The companies have had a second New Drug Application (NDA) accepted by the Food and Drug Administration (FDA) for the use of the sodium glucose co-transporter 2 (SGLT-2) inhibitor Forxiga (dapagliflozin) in the treatment of adults with type 2 diabetes.
This resubmission contains details from several new studies and additional long-term data in response to the request made by the FDA in its complete response letter in January 2012 for extra information about Forxiga’s benefit-to-risk profile.
In total, the study programme to support Forxiga’s submission now contains data from more than 26 phase II/III clinical trials involving more than 12,000 adult patients with diabetes.
One of the main areas for concern in the FDA’s initial response was the safety profile of Forxiga, which works by blocking the reabsorption of glucose in the kidneys and promoting the excretion of excess glucose in the urine.
The drug has been linked to an increased risk in liver damage and breast and bladder cancer, and data provided by AZ and BMS in its first attempt for approval was not enough to allay the regulatory agency’s fears, with the FDA on high alert for diabetes drug safety since GlaxoSmithKline’s Avandia (rosiglitazone) was linked to an increased risk of cardiovascular events.
Since then, Forxiga has been approved in several other regions, including Europe, Australia, Brazil, Mexico and New Zealand, and this new data could help satisfy the FDA that the drug’s benefits, such as a reduced risk of hypoglycaemia and weight gain, offset its risks.
If so, it would follow a similar path to that of the National Institute for Health and Care Excellence (NICE) – the health technology assessment body for England and Wales – which initially failed to back Forxiga for NHS use, but overturned this decision once the companies’ presented more data.