Tuesday, July 19, 2011

Dapagliflozin - FDA Advisory Committee Meeting Recommendation

Yesterday, FDA Advisory committe recommended against dapagliflozin approval.  This is in line with my expectation and I beleive the negative vote will also have implication for a hoard of SGLT2's in pipeline.  Probably these candidates will have to conduct larger and longer PhIII studies going forward. FDA will look at clinical data in conjunction with preclincial data to decide on these pipeline drugs.  The decision is influenced by the caution among the regulators due to  Meta-analysis of Actos data revealing association of Actos with bladder cancer.
A positive implication of  a delay in approval of SGLT2's is that GLP-1's will get a boost.  I expect EU reguators to also follow suit and recommend against dapagliflozin. LLY's once weekly GLP-1 - Bydureon, which has recently received EU approval, would be able to reap benefit of the caution on the use of Actos and delay of SGLT2.