Biotech Values

[DewDiligence]

Re: Timing of FDA approval for ABBV/ENTA’s 3-DAA regimen

AbbVie announced it expects U.S. launch [of 3-DAA HCV regimen] in 2014.

ABBV/ENTA’s 3-DAA regimen has an FDA Breakthrough Therapy Designation, which ensures a priority review of <=8 months. With the NDA submission planned for April, an FDA review lasting less than the full 8 months would conclude during 2014. Hence, ABBV’s updated guidance for a product launch in 2014 presumes that the FDA will take somewhat less than the full 8 months to review the NDA, which seems reasonable given the strength of the dataset.

An alternative interpretation of ABBV’s revised guidance for a 2014 product launch is that ABBV hopes to beat its own guidance for an NDA submission in “early 2Q14” by submitting the NDA in March.