Memorandum
Novo Nordisk announced on Tuesday that the FDA has accepted its Class II Resubmissions for the ultra-long-acting basal insulin Tresiba (insulin degludec) and the premixed insulin Ryzodeg (insulin degludec/insulin aspart). For background, the company announced on March 26th that a small firewalled group within the company with access to unblinded data from the DEVOTE cardiovascular outcomes trials (CVOT) decided with FDA input to go ahead with the resubmission – this group will continue to liaise with the Agency. We do not expect an AdComm, as that would require unblinding interim data from DEVOTE (which is still ongoing and expected to completely in 2H16). In the press release in late March, Novo Nordisk guided for FDA submission in the following month. The FDA’s acceptance of the resubmission this week places the timeline impressively ahead of that guidance, as in the 12 days since the first announcement the company resubmitted the NDAs and the FDA confirmed acceptance for review (this generally does not happen immediately upon receipt). The FDA’s timeline for a Class II Resubmission is six months following acceptance, placing the deadline in early October. Sanofi’s Toujeo (insulin glargine U300), destined to be one of Tresiba’s primary competitors, was launched in the US barely a week ago. Lilly/BI’s biosimilar insulin glargine is on hold due to a Sanofi patent lawsuit while Lilly’s novel basal insulin peglispro (BIL) suffered a setback due to liver safety data in phase 3 that will push any NDA submission beyond 2016.