Takeda Pharmaceuticals' shares rose to their highest level in four years this week, after the company won Food and Drug Administration (FDA) approval for its new diabetes drug, alogliptin, Bloomberg reported.
This comes as welcome news to the drug maker, which suffered a drop in sales after it lost the patent for its blockbuster diabetes drug Actos. The drug had accounted for 27 percent of the company's revenue.
But the company could suffer financial setbacks from lawsuits filed by individuals who took Actos and are suffering from bladder cancer, congestive heart failure, lactic acidosis and other side effects. The number of lawsuits is expected to reach 10,000.
Diabetes is big business for many pharmaceutical companies. In the United Sates, 25.8 million people have diabetes, and it is believed that another 7 million remain undiagnosed. Takeda is developing three new diabetes drugs.
According to Medscape Today, the FDA approved three different formulations of Takeda's new drug. The FDA last week announced the approval of Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride) and Oseni (alogliptin and pioglitazone). The medications are indicated to control blood glucose levels in people with type 2 diabetes in combination with diet and exercise.
Alogliptin works by slowing the inactivation of the hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide)–hormones involved in regulating blood glucose levels. The new drug is part of a class of medications called DPP-IV inhibitors, the fourth to be approved by the FDA.
FDA Previously Denied Alogliptin
Prior to approving alogliptin this year, the FDA rejected Takeda's first and second applications.
The FDA released new cardiovascular safety requirements following the startling number of life-threatening heart problems suffered by people on Avandia, another diabetes drug. The agency cited insufficient cardiovascular data for alogliptin and forced Takeda back to the drawing board with the medication in 2008. Then, it requested additional data in 2012 after reviewing the company's second application in 2011.
One of the reasons the FDA may have delayed the approval of alogliptin is that this is not the first time Takeda has had problems with insufficient data.
When the company released Actos in 1999, it disclosed that lab rats using Actos had developed bladder tumors. It did not warn clearly and fully of the risk of Actos-related bladder cancer in humans. After a number of Actos users developed bladder cancer and Takeda's 10-year study revealed a link to the cancer with long-term use of Actos, the FDA issued a warning and required Takeda to add a warning to the drug's packaging.
Takeda Continues to Profit from Actos
The patent for Actos (pioglitazone) may have expired, but Takeda still stands to make a profit from its former blockbuster diabetes drug.
That's because one of the new approved drugs, Oseni, is a mixture of alogliptin and pioglitazone. Now there is concern that Oseni may pose the same bladder cancer risks because this formula also uses pioglitazone.
In the meantime, Oseni will carry a black-box warning for heart failure. The FDA is also requiring increased postmarket monitoring for severe adverse events for Oseni and the two other formulations of alogliptin. These adverse events include liver abnormalities and pancreatitis.
Other drugs in the same class as alogliptin include Januvia (sitagliptin, Merck), Onglyza (saxagliptin, AstraZeneca and Bristol-Myers Squibb) and Tradjenta (linagliptin, Boehringer Ingelheim and Lilly). Januvia has made news after a study linked it to an increased risk of pancreatitis and pancreatic cancer. The FDA required Merck to include a warning.