EMPA-REG Data Will Boost Jardiance's Role In Combination Therapy, Lilly Says
Large outcomes trial showing a cardiovascular benefit with empagliflozin could shift the treatment landscape to earlier use of the SGLT2 inhibitor in combination therapy rather than replacing treatment with metformin and other agents, Lilly Diabetes President Conterno predicts.
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FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.
A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.