J&J Gains FDA OK For First-In-Class Type 2 Diabetes Drug Invokana
This article was originally published in The Pink Sheet Daily
J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.
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A new frontier in diabetes care is set to open in India with the Special Expert Committee giving a green light to AstraZeneca’s dapagliflozin, after holding back on safety concerns for a prolonged period.
Some analysts expect it could take six months to resolve problems at partner Boehringer Ingelheim’s German manufacturing site, where the SGLT-2 inhibitor is made. Lilly says the European filing is not affected.