AZ and BMS go for second Forxiga submission
pharmafile | July 29, 2013 | News story | Sales and Marketing |Â Â AZ, BMS, FDA, ForxigaÂ
AstraZeneca and partner Bristol-Myers Squibb have resubmitted their diabetes drug Forxiga to the FDA 18 months after it was rejected over safety concerns.
Forxiga (dapagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor – a protein in the kidneys that allows glucose to be reabsorbed into the bloodstream – improving glycaemic control without increasing insulin secretion.
Its major difference to other drugs is that it works independently of insulin to help remove excess glucose from the body for type 2 diabetics.
The drug received European approval in late 2012 but was knocked back by the FDA last year, which wouldn’t pass it on safety grounds.
Specifically, Forxiga was linked to an increased risk in liver damage and breast and bladder cancer. Both firms had submitted extra data last year to ease the US regulator’s anxiety over its drug, but it wasn’t enough to sway the FDA.
AZ and BMS said that the resubmission of its treatment includes several new studies and additional long-term data (up to four years’ duration) from previously submitted studies. This, the firms hope, will help reverse the concerns that led to its rejection last year.
The FDA said it has assigned a new Prescription Drug User Fee Act goal date of 11 January next year for the treatment.
New competition
Peak sales estimates for Forxiga were around $700 million, but could be tipped over the blockbuster mark if it does receive full FDA backing.
But these estimates may need to be revised after Janssen received US approval for its competing treatment Invokana (canagliflozin), which works in a similar way to Forxiga.
Some diabetes drugs, in particular GlaxoSmithKline’s Avandia, have put regulatory agencies on high alert because of increased heart attack risk. GSK’s once blockbuster drug is now restricted in the US and banned from sale in Europe because of these safety worries.
This may be why Forxiga has come under greater scrutiny, and although approved, the FDA has told Janssen it must conduct five additional long-term studies of Invokana’s effects on cardiac health, liver problems, cancer, and pancreatic disease.
If Forxiga gains marketing approval it too will most likely have to conduct similar long-term safety studies.
Ben Adams
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