A treatment which is commonly used for diabetes has received a lot of attention from mainstream media, regulators and the research community. Together, the reports point to the treatment being approved for obesity treatments. Here we consider the opinions from FDA regulators to these reports, along with the implication it has for the future of obesity treatment.
The active ingredient that has been considered is called Liraglutide. It is an essential component of the diabetes medication Victoza and aids the production of insulin. Based on the studies to date it is believed that taking a treatment that is aiding the production of insulin whilst maintaining exercise and a healthy diet leads to higher weigh loss than merely exercising and eating healthy. If approved, then the treatment would have a higher dosage than the current diabetes prescriptions and go under the name Saxenda.
Early in September this year a report was published on the FDA website. The key message indicated that Liraglutide should be considered as a potential candidate for obesity treatment as long as safety questions were addressed. This relates primarily to the finding that a slight increase of breast malignancies that had been reported among women who received the treatment. However, FDA were quick to state that this limited data is insufficient in conclusively supporting or denying the potential role of the drug in cancer being developed or progressing if already diagnosed.
Following this report an advisory panel heard 20 public witnesses, along with a handful of obesity sufferers. They considered known data about the side effect of using Victoza, along with published studies that have investigated the use of Liraglutide in weight-loss. Based on this, 14 out of 15 panellists endorsed further studies to give serious consideration to the topic. This is promising, as FDA is known for adhering to recommendations from their advisory panels. It implies that approval is closer, and has been reflected in the rise of the manufacturer’s share price.
While it is not currently known how long it will take before the treatment is out on the market, we do know that a verdict for the US approval has been set by 20th of October 2014. It is also likely that US approval will follow in Europe and we expect a decision before the end of the year. More inforation can be found here.
We have noted that some UK websites have already started selling this medication before it is approved in the EU. Whilst this is entirely legal as doctors are allowed to prescribe medication off-label, we are not sure that this is advisable. You can have a look at one of the websites to see what they are up to in this regard – Private Doctor Direct.