The FDA has approved Novo Nordisk’s new Diabetes drug Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in adults. Victoza, also known as Liraglutide, was launched in European markets in 2009 and has gained regulatory approval in Japan last week. Victoza belongs to a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help the pancreas make more insulin after eating a meal.

Generex Biotechnology Corporation has been granted price approval by the US Food and Drug Administration approval for the use of Generex Oral-lyn(TM) under the FDA’s Treatment Investigational New Drug (IND) program. Generex was previously granted the FDA approval for the use of Generex Oral-lyn(TM) in patients with Type 1 or Type 2 diabetes mellitus under the FDA’s “Treatment IND” rules.

The prescription drug Avandia (rosiglitazone), marketed as a treatment for Type II diabetes, causes an increase in liver problems, heart problems and bone density problems resulting in fractures. It has been linked to cases of death due to liver failure and heart failure. Patients who have a history of certain medical conditions, such as heart disease, heart attack, high blood pressure, smoking and stroke, and those taking medications including diuretics, steroids, seizure medication and thyroid medication are more prone to experiencing serious side effects while taking Avandia.

The U.S. Food and Drug Administration has approved Sanofi-aventis’ Apidra (insulin glulisine injection) to recover glycemic control in children above the age of 4 years suffering from diabetes mellitus. The approval for pediatric use of the injection is based upon FDA’s review of a 6 month long phase III study involving 572 children with type 1 diabetes. Apidra(R), having a rapid onset and shorter period of action, should normally be used along with a basal insulin with a longer duration of action. The product can also be applied in insulin infusion pump treatment for controlling blood sugar.

Data obtained from a new study GALIANT shows Galvus® (vildagliptin), an oral treatment for type 2 diabetes, is better tolerated and as effective as commonly prescribed anti-diabetic oral medicines, called thiazolidinediones (TZDs), when added to metformin. Galvus also eliminates a common side effect of other type 2 diabetes medicines – weight gain, by providing for control of body weight . Other data presented also demonstrated the favorable cardiovascular safety profile of Galvus and confirmed its tolerability in patients with mild-to-moderate renal impairment. A lower overall incidence of adverse cardiovascular events was recorded.

The patient screening process for the Phase III program of the Generex Biotechnology’s oral insulin spray Generex Oral-lyn has been started in North America. The company is expected to enroll 750 patients suffering from Type 1 diabetes mellitus. The company intends to use the study to compare Generex Oral-lyn and the RapidMist diabetes management system with usual insulin therapy.