US FDA approvals tracker: August

From a total of 13 marketing decisions expected from the FDA, August saw eight approvals and three complete response letters. Notable regulatory nods included two Jak inhibitors: Abbvie’s rheumatoid arthritis drug Rinvoq and Celgene’s myelofibrosis therapy Inrebic; the latter was not included in Vantage's August PDUFA analysis as it had been due a decision in September. Both products came with label warnings that could limit their uses, namely thrombosis for Rinvoq and encephalopathy for Inrebic. Meanwhile, Sarepta got a knockback for its follow-on Duchenne therapy Vyondys 53, with the company citing the risk of infection at intravenous infusion ports and kidney toxicity. Important decisions due this month include the oral version of Novo Nordisk's GLP1 agonist semaglutide (Go or no go? Novo awaits call on oral sema, August 30, 2019).