Diabetes Signs And Symptoms

Fate of Bristol Myers' Dapagliflozin Rests With an FDA Advisoy Committee

Overview and Investment Thesis

The strong Bristol-Myers ( BMY ) pipeline story is key to the investment thesis and is driven by three potential blockbusters: Yervoy, which was just approved; apixiban which has reported very encouraging phase III data and is likely to be approved in 2012; and dapagliflozin. Of the three, the outlook for dapagliflozin is the most uncertain. Without dapagliflozin, the pipeline story is very good. With dapagliflozin, it is very, very good. I can with equal conviction come up with a scenario in which dapagliflozin is a blockbuster and another in which it is a niche product. I look forward to the advisory committee meeting to gain an insight into how experts view the drug.

Bristol-Myers is developing dapagliflozin, the first of a new class of oral anti-diabetic agents for type II diabetes. The NDA was accepted for review by the FDA on March 2011 and the PDUFA date was set for October 28, 2011. The Endocrinologic and Metabolic Drugs Advisory Group to the FDA will meet on July 19, 2011 to consider the NDA and give advice pertinent to its approvability; the FDA has the final decision. The FDA will make available public briefing papers prepared for the committee shortly before the meeting. These give valuable insights into the FDA’s analysis of the drug.

I think that the majority of investors are expecting the FDA to issue a Complete Response Letter at the PDUFA date as this has become almost routine with novel new drugs such as dapagliflozin. The exceptions are drugs that address an unmet need in a potentially deadly disease like some types of cancer. Because diabetes can be effectively treated by several other therapies, there is a general expectation that the FDA will want more long term safety data and other information before approving the drug.

The tone and manner of the discussion at the advisory committee may allow investors to judge three possible outcomes at the PDUFA date: (1) the drug will be approved, (2) a complete Response Letter will be issued but no new trials will be required or (3) a Complete Response Letter will be issued and some type of new trials will be required.

Dapagliflozin Treats Type II Diabetes Using a New Mechanism of Action

Dapagliflozin has been viewed with both great interest and caution by physicians and investors because it employs a new, unique mechanism of action to treat type II diabetes. In the kidney, glucose is filtered at the glomerulus and then reabsorbed via active transport mechanisms in the tubule. Two sodium glucose co-transporters are responsible for this reabsorption, SGLT-2 and SGLT-1. SGLT-1 accounts for about 10% of the reabsorption and SGLT-2 accounts for 90%. Dapagliflozin inhibits SGLT-2 preventing the reabsorption of glucose and causing more glucose to be excreted in the urine.

The Signs of Diabetes in addition to Diabetes Symptoms | Treatment ...

How many persons experiencing diabetes is increasing yearly. It is a disease the place that the particular person has increased a higher level carbs and glucose in the system while the amount of sugar and carbohydrates from the tissue is leaner in comparison with expected.

There usually are home equity loans diabetes Type One particular diabetes Type 3 diabetes

In type 1 diabetes there is a lack or even finish unavailability regarding hormonal agent insulin. This can be a bodily hormone introduced by pancreas and it assists the blood sugar by body to penetrate the body.

In type 1 diabetes there is a insufficiency or perhaps complete unavailability of hormonal agent the hormone insulin. This is the endocrine launched by pancreas and it also will help this blood sugar through blood to go into the body.

In type 2 diabetes pancreatic is definitely making bodily hormone insulin though the solar cells grow to be inefficient to respond properly on the way to blood insulin. Cures is actually classified as insulin shots opposition. Unluckily such type of diabetes remains unseen for a longer time period because it has the signal are usually associated with subtle dynamics.

Signs regarding both equally types of diabetes are often incorrectly recognized for a lot of unique circumstances, illnesses along with other ecological elements. The most typical sign of diabetes is usually considerable however baffling decline inside bodyweight on the target. That signal can be easily seen in scenario connected with variety One diabetes patients nonetheless this specific warning is pretty significantly less detectable in case there is diabetes form 2.The explanation for this particular serious displaced inside excess fat is that body actually starts to breakdown equally extra fat along with lean muscle mass with the output in the event that vigor.

The subsequent most frequently overlooked warning will be pressing hunger in addition to a too much craving for you to pee. Usually the responsibility on this signal travels to exercise, climatic conditions or a number of other points and not diabetes. This indication with scenario with diabetes would be the result of abnormal taking with water by means of filtering organs regarding watering down this concentration in case sugars with pee. This leads to contamination and even extreme hunger.

The up coming sign of diabetes is definitely constant a sense of remaining fatigued likewise some sort of depleted. This sign is sometimes confused with a great many other elements. Yet it’s crucial that you notice how frequently will you those believes exhausted as well as for the time these feelings persists. Your symbol of tiredness will have to not be dismissed in vase with older folk individuals.

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