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Diabetes drug dapagliflozin wins support of FDA advisory committee
#1
Bristol-Myers and Astra Zeneca have received a welcome recommendation from an FDA advisory panel on their proposed diabetes drug dapagliflozin. This is all the more welcome as the same panel previously came out against the same drug in 2011, resulting in FDA rejection, due to concerns over incidences of bladder cancer in trial treatment groups.

Dapagliflozin is one of a range of new anti-diabetes medications being developed in response to the near-epidemic levels of diabetes, particularly in westernised countries. It is an inhibitor of the SGLT2 member of the family of sodium-dependent glucose transport proteins (SGLT), comprising SGLT1, SGLT2 and SGLT3. SGLT2 is mainly found in the S1 segment of the proximal tubule of the kidney and is chiefly responsible for mediation of renal glucose reabsorption. By inhibiting SGLT2, dapagliflozin can help improve glycaemic control in type 2 diabetes mellitus (T2DM) patients due to reduction of renal glucose reabsorption leading to urinary glucose excretion (glucuresis). The previous FDA rejection of dapagliflozin had initially led to fears that the whole class of drugs could be rejected. However, in the meantime Johnson and Johnson won FDA approval for their SGLT2 inhibitor canagliflozin.

Since the initial rejection, Astra Zeneca and Bristol-Myers have worked on the safety profile of dapagliflozin and for example have demonstrated that the drug has beneficial effects on CV risk factors in T2DM patients. The extra data has been enough to sway the FDA advisory panel that the potential benefits of dapagliflozin outweigh the risks. In addition, the drug is already available in Europe under the name of Forxiga. The delay in approval has inevitably eroded the prospective market share in the USA for dapagliflozin. Estimates of its potential value to the companies have been reduced from $700 million to $300 million per year. However, the companies are now hopeful that the opinion of the advisory committee will result in FDA approval by February 2014.

Sources

CASTANEDA-SCEPPA, C. and CASTANEDA, F., 2011. Sodium-dependent glucose transporter protein as a potential therapeutic target for improving glycemic control in diabetes. Nutrition reviews, 69(12), pp. 720-729.

GUDE, D., 2012. Red carpeting the newer antidiabetics. Journal Of Pharmacology & Pharmacotherapeutics, 3(2), pp. 127-131.

KASICHAYANULA, S., LIU, X., LACRETA, F., GRIFFEN, S.C. and BOULTON, D.W., 2013. Clinical Pharmacokinetics and Pharmacodynamics of Dapagliflozin, a Selective Inhibitor of Sodium-Glucose Co-transporter Type 2. Clinical pharmacokinetics, .

PTASZYNSKA, A., HARDY, E., JOHNSSON, E., PARIKH, S. and LIST, J., 2013. Effects of dapagliflozin on cardiovascular risk factors. Postgraduate medicine, 125(3), pp. 181-189.

ZHANG, M., ZHANG, L., WU, B., SONG, H., AN, Z. and LI, S., 2013. Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes/metabolism research and reviews, .

http://www.fiercebiotech.com/story/fda-p...2013-12-12
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Diabetes drug dapagliflozin wins support of FDA advisory committee00