Four Type 2 Diabetes Drugs Approved in 3 Months, Not Good Enough

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In just 3 months, the Food and Drug Administration (FDA) has granted approval to four type 2 diabetes drugs, including Invokana, which is the first in its class. Yet while adding new items to the expanding type 2 diabetes drugs arsenal has its positive side, it’s not good enough, and here’s why.

Do we need four new type 2 diabetes drugs?

It’s no secret that type 2 diabetes is a growing epidemic, and that an increasing number and percentage of children and adolescents are developing this disease that was once largely seen only in adults. For young people in particular, onset of type 2 diabetes at an early age places them at greater risk for a lifetime of health complications and a shorter life span.

The four new type 2 diabetes drugs that won FDA approval since January 2013, including the latest, Johnson & Johnson’s Invokana (canaglifozin), provide current and future type 2 diabetics with more pharmaceutical treatment options. Before looking at those four new options, let’s consider how much they are needed.

Regardless of which drug class the current litany of type 2 diabetes medications fall into—biguanides, sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 inhibitors (DPP4i), insulin, and now the newest class, sodium-glucose co-transporter 2 (SGLT2) inhibitors—all share one characteristic: they are designed to be used along with diet and exercise to manage the disease.

Type 2 diabetes is a disease of lifestyle: nearly every risk factor for type 2 diabetes involves choices people make and can change: being overweight, lack of exercise, high cholesterol, high blood pressure, impaired glucose tolerance.

Proper diet and nutrition along with regular physical activity and weight management can both prevent type 2 diabetes and even reverse it in some individuals. They certainly can allow people to manage it better and even allow them to significantly reduce the need for medications.

Thus, while increasing the number of type 2 diabetes drugs on the market gives people with diabetes more medication choices, it also provides them with more ways to avoid taking proactive, aggressive steps to prevent and manage the disease without the drugs. This is all good news and money for drug makers and the healthcare industry, but not so good for healthcare consumers.

That said, here are the four new additions to the drug chest for type 2 diabetes.

Four new type 2 diabetes drugs
Invokana was approved by the FDA on March 29, 2013, and is the first drug in the SGLT2 class. It works by stopping the kidneys from reabsorbing sugar (glucose), increasing the amount of glucose that is excreted, and reducing glucose levels in the blood. In Phase III trials, the new drug also helped reduce systolic blood pressure and body weight in some patients.

Invokana has been studied as monotherapy and along with metformin, insulin, pioglitazone, and sulfonylureas. Side effects reported during trials included urinary tract infections and vulvovaginal candidiasis. The drug also may cause a sudden drop in blood pressure, causing dizziness or fainting.

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The FDA needs a number of post-marketing studies of Invokana, including a cardiovascular outcomes trial to look for photosensitivity, liver abnormalities, malignancies, serious pancreatitis, adverse pregnancy outcomes, and severe hypersensitivity reactions. Other post-marketing studies include one for bone safety and two on children.

Nesina (alogliptin), Oseni (alogliptin and pioglitazone), and Kazano (alogliptin and metformin hydrochloride) were approved in January 2013. Alogliptin, a type of DPP-4i, is the new kid on the block, while pioglitazone and metformin have had FDA approval for years.

Alogliptin tablets, along with other DPP-4 inhibitors, slow down the inactivation of incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). The bottom line is, DPP-4 inhibitors helps stimulate the release of insulin after eating, ultimately resulting in better control of blood sugar levels.

The most common side effects of alogliptin were found to be headache, runny nose, and upper respiratory tract infections. Five post-marketing studies are still required by the FDA: “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).”

Kazano, which combines alogliptin and metformin hydrochloride in one tablet, is associated with the same side effects as Alogliptin alone as well as sore throat, hypertension, diarrhea, back pain, and urinary tract infections. The FDA still wants two post-marketing studies for this drug: one for safety and efficacy in pediatrics, and one for liver abnormalities, pancreatitis, and hypersensitivity reactions.

Oseni is a combination of alogliptin and pioglitazone and is the first drug offered in the United States that includes both a thiazolidinedione and a DPP-4 inhibitor. Because of the presence of pioglitazone, Oseni has a boxed warning concerning a risk of heart failure.

The most common side effects associated with Oseni were found to be runny nose, sore throat, back pain, and upper respiratory tract infections. One post-marketing study is needed by the FDA for liver abnormalities, pancreatitis, and hypersensitivity reactions.

A January 25, 2013 report from the FDA noted that there are 24 million Americans with type 2 diabetes, and the number keeps rising. Millions more have prediabetes.

We keep adding more and more drugs to the medication chest for type 2 diabetes, yet it is not enough. More needs to be done to convince and educate people to take actions that can eliminate or at least significantly reduce their need for such type 2 diabetes drugs.

Also Read: Curcumin, Prediabetes and Type 2 Diabetes: New Study
Type 2 Diabetes and Beta Blockers, What You Should Know
Two Type 2 Diabetes Drugs Under Investigation

SOURCES:
FDA news release January 25, 2013
FDA news release March 29, 2013
Takeda news release

Image: Morguefile

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