J&J Defends Invokana Safety Track Record, Amid FDA’s SGLT2 Review
J&J’s push to expand the successful drug to earlier use and more labeled indications is under a shadow due to the risk for diabetic ketoacidosis, but it said the condition is very rare and endocrinologists caution against reading too much into case reports flagged by FDA.
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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.
Gilead’s Sovaldi earned a spot in the record books – and the hearts of drug marketers – generating $8.55 billion in the first nine months of 2014. Despite controversy over Sovaldi’s high price, Gilead defended the drug’s value and executed flawlessly on the launch. Other 2014 drug launches were slow out of the gates, as the bar for new drugs continues to grow.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.