The active ingredients pioglitazone and metformin hydrochloride are already approved by the FDA for type 2 diabetes management - Alogliptin is new.
According to the FDA in a communiqué issued on January 25th, 2013, 24 million Americans live with type 2 diabetes, which accounts for over 90% of all diabetes cases in the country.
Patients with type 2 diabetes either do not produce enough insulin, or are resistant to it - in both cases their blood sugar levels are too elevated. Eventually, high blood sugar levels can lead to serious and life-threatening complications, such as kidney damage, blindness and heart disease.
Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said:
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes. Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
Nesina, Oseni and Kazano were studied as monotherapies and also in combination with insulin and sulfonylureas. A monotherapy is a stand-alone therapy, one that is not given in combination with another drug.
These therapies should not be prescribed for patients with type 1 diabetes or people with diabetic ketoacidosis (high ketone urine levels).
Nesina (alogliptin) tabletsNesina is a DPP-4i (dipeptidyl peptidase-4 inhibitor). It is designed to slow down the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).
Nesina (alogliptin) was shown to be both effective and safe in 14 human studies, which included 8,500 participants; all of them with type 2 diabetes:
- Patients on Nesina had reductions in HbA1c (glycosylated hemoglobin) of 0.4% to 0.6% compared to those on placebo after 26 weeks on the medication
- The FDA says it needs five post-marketing Nesina studies: "a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies under the Pediatric Research Equity Act (PREA), including a dose finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin."
- Nesina's most commonly reported side effects included upper respiratory tract infection, headache, and runny nose.
Kazano (alogliptin and metformin hydrochloride) tabletsKazano is a combination of alogliptin and metformin HCl, a extensively used anti-diabetes medication, in a single tablet.
Kazano was shown to be both safe and effective in four clinical trials, which included over 2,500 participants, all of them with type 2 diabetes:
- Those on Kazano had additional reductions in HbA1c of 1.1% over Nesina, and 0.5% over metformin after being on therapy for 26 weeks
- The FDA says it needs two post-marketing Kazano studies: a pediatric efficacy and safety study under PREA, and an enhanced pharmacovigilance program to check for liver abnormalities, pancreatitis, and severe hypersensitivity reactions
- It carries a Boxed Warning regarding lactic acidosis (accumulation of lactic acid in the bloodstream), which is linked to metformin use
- The most commonly reported side effects related to Kazano were stuffy/runny nose, sore throat, headache, hypertension, diarrhea, back pain, urinary tract infection, and upper respiratory tract infection.
Oseni (alogliptin and pioglitazone) tabletsOseni, a combination of alogliptin and pioglitazone, is the first medication in the USA to include both a DPP-4i and a TZD (thiazolidinedione) in a single tablet.
Oseni was shown to be both safe and effective in four clinical trials which included over 1,500 participants, all of them with type 2 diabetes:
- The patients on Oseni had additional reductions in HbA1c of 0.4% to 0.6% over pioglitazone alone, and 0.4% to 0.9% over alogliptin alone
- The FDA says it needs an enhanced pharmacovigilance program for Oseni to check for abnormalities of the liver, pancreatitis, and severe hypersensitivity reactions
- There is a Boxed Warning in the Oseni packaging, warning about heart failure linked to pioglitazone use
- The most commonly reported side effects related to Oseni are sore throat, runny nose, upper respiratory infection, and back pain.
Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc., said:
"Takeda is pleased with the FDA approval of NESINA, OSENI and KAZANO for the treatment of type 2 diabetes, a therapeutic category in which we have more than twenty years of clinical and patient experience. Millions of people are affected by diabetes and, as a leader in the diabetes arena, Takeda is dedicated to working to advance patient care and helping to meet the needs of this growing patient population."
According to Takeda, type 2 diabetes is a "progressive and chronic (long-term) condition." Patients should work with a doctor to manage and monitor their disease. As well as adhering to a diet and exercise program, patients need to take several drugs in order to help them manage their blood glucose levels.
Currently, approximately $471.6 billion are spent annually worldwide on diabetes (both types 1 and 2). The International Diabetes Federation estimates that this yearly expenditure will rise to over $595 billion within the next 17 years.
Written by Joseph Nordqvist