GlaxoSmithKline Diabetes Drug Approval Closer

GlaxoSmithKlineGlaxoSmithKline continues its effort to gain approval for the new drug, albiglutide, which is designed to help those with type 2 diabetes. Despite setbacks over the past year, the company received two thumbs up from the Committee of Medicinal Products for Human Use of the European Medicines Agency. The agency’s positive opinion brings the approval of albiglutide, also known as Eperzan, closer to reality.

The good news for GlaxoSmithKline comes after a slight delay back in August 2013 when the FDA asked for extra time in making their approval decision. The three-month delay means they won’t reach a decision until mid April, giving competitors the upper hand.

The opinion coming from Europe is based on global studies involving more than 5,000 participants, including clinical trials. One study, led by Dr. Julio Rosenstock and his team, was published in Diabetes Care. They studied 774 participants in a randomized trial for 16 weeks. Participants had type 2 diabetes and were already taking the glucose lowering drug metformin. They were given various doses of albiglutide, either 30, 50 or 100 milligrams in weekly, bi-weekly and monthly doses.

The experimental drug, when paired with metformin, showed mixed results. Although it showed good results in lowered blood glucose in diabetic patients it increased gastrointestinal problems. As with any prescription drug, there are unwanted side effects. Common issues during the trial included nausea, vomiting, headaches, dizziness, back pain, the flu, respiratory tract infections and skin reaction at the site of injection. Side effects were lessened with the lower, more frequent dose.

Positive side effects revealed in the study were weight loss and lowered blood pressure. This could set albiglutide apart from its competition since losing weight is often the first suggestion doctors make to their diabetic patients, yet the majority of drugs on the market for this condition actually promote weight gain, making it more difficult to manage.

Managing type 2 diabetes can be challenging. The body becomes resistant to insulin and it’s impossible to regulate blood sugar. It’s the blood sugar spikes that are concerning. While these can generally be controlled through diet and exercise, drugs are often prescribed to keep the blood sugar level and avoid the peaks and valleys. Mismanaged diabetes can lead to irreversible damage, including blindness, loss of limbs and premature death. Having a treatment plan in place for prevention is ideal. GlaxoSmithKline continues to push for approval and is getting closer for their newest diabetes drug approval for this reason.

The single dose injection is a new product for the GlaxoSmithKline and it makes life for diabetic patients a little easier because they don’t need to mess around with daily injections, but they will not be the first to put a weekly injection on the market.

Albiglutide is the latest drug by GlaxoSmithKline drug that has been tested for the treatment of type 2 diabetes. It’s a once a week injection that is shown to be effective when paired with proper diet and exercise. It also has the ability to be combined with other glucose-lowering medications. The drug hasn’t gotten approval anywhere yet, but as the approval date for the U.S. FDA draws closer, the opinion from Europe’s committee is a good sign.

By Tracy Rose

Fierce Biotech
Diabetes Care

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