The FDA's expanded approvals were supported by data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies (GO-VIBRANT and GO-ALIVE) that included >600 patients.
In clinical trials, treatment with Bydureon BCise resulted in average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds when used as monotherapy or as an add-on to metormin, a sulfonylurea, a thiazolidinedione, or any combination of two of these agents, at 28 weeks.
The use of Shingrix also decreased the overall incidence of postherpetic neuralgia (PHN).
The Company has decided in conjunction with the FDA to suspend further administration of Octagam 10% from these specific production lots.
Patients can also track and monitor their heart rhythms at any time and view the history of their clinician transmissions without having to contact their clinic.