Genisi - Re - Biodel - the disposable pen will be submitted as an NDA supplement or addendum. A reusable pen using 3 ml cartridges is included in the current NDA, plus the 10 ml vial form.
In addition to the bothched Indian data, some other questions surrounding Viaject's approval include -
1) The presence of the chelating agent EDTA in Viaject. EDTA is the key to Viaject's ultra fast activity - it chelates the zinc locus where insulin clumps into inactive hexamers. So in Viaject, insulin is in its active monomer form when injected. EDTA is 'GRAS' (generally regarded as safe), but will the FDA have safety concerns over injecting EDTA multple times daily over a patient's entire lifetime?
2) Formulation changes made after the Phase 3s. The efficacy data generated in the Phase 3s was obtained using a different Viaject formulation than what is in the NDA. They used a two part mix of lyophilized insulin plus Biodel's proprietary diluent at an acidic pH 4 in the Phase 3s, vrs the premixed formulation buffered to neutal pH 7 being filed for in the NDA. There is no comparative efficacy data for the version being filed for, only a bioequivalence study. The pH change could conceivably have an effect on efficacy because part of Viaject's ultra fast activity (in addition to the EDTA additive) comes from the use of citric acid, which prevents re-clumping of insulin back into inactive hexamers. So changing the pH could conceivably change the efficacy profile.
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