Is There a New Indication for Actos in the Works?

Washington, DCAs litigation surrounding Actos bladder cancer continues to heat up, Actos manufacturer Takeda Pharmaceuticals is facing another challenge—the expiry, in a little over three months, of patent protection for Actos. When that happens, various generics by other manufacturers of pioglitazone (Actos) will flood the market with cheaper alternatives to Actos.

Individuals, HMOs and publically funded organizations such as Medicare and Medicaid will be snapping up cheaper generics, and doctors will be asked to prescribe the less-expensive generics as well.

Actos, a drug designed to treat Type 2 diabetes, became the go-to drug for a time following the Avandia meltdown of a few years ago. Sales of Actos soared. But then came concerns over Actos side effects, including concern over Actos and bladder cancer.

Actos heart failure is another concern. A whistleblower Actos lawsuit filed in June 2010 and recently unsealed alleges that Takeda suppressed some cases of Actos heart failure, in turn failing to report all cases to the US Food and Drug Administration (FDA).

Takeda, in the meantime, has been working on a successor drug as a means of replacing the lost revenue stemming from the patent expiry for Actos.

But here, Takeda is facing a series of roadblocks. The initial application for alogliptin was rejected by the FDA in 2009, with the drug regulator asking for additional information on cardiovascular risks.

Late last month, on April 26, Takeda issued a statement revealing the FDA has again rejected alogliptin for the US market, although it is marketed in other countries including Japan, branded there as Nesina. According to a report in Bloomberg News (4/26/12)Bloomberg), Takeda wants to ensure they can continue tapping into that market. Alogliptin is an important part of that strategy.

But Actos is not dead yet, or so it appears. According to the online portal of The Daily Mail, more than a quarter of a million Brits take Actos for diabetes. Now, new research is suggesting that using Actos in tandem with an antidepressant boosts the effects of the antidepressant whether or not a patient even has diabetes.

The research, published online in the journal Neuropsychopharmacology, is preliminary. But it could hold promise for a new indication for Actos. The question becomes, then—will a new indication also result in even more cases of Actos bladder cancer and other Actos side effects, were it to be approved for an indication other than diabetes? Antidepressants are widely prescribed in the US…