Amgen looks to expand access to Otezla in the US
Amgen has submitted a supplemental new drug application (sNDA) seeking expanded approval for Otezla in adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
The submission to the US Food and Drug Administration (FDA) is based on data from the Phase III ADVANCE trial.
In this trial, Otezla (apremilast) 30mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response compared to placebo, at week 16.
In addition, Otezla demonstrated statistically significant improvements in key secondary endpoints compared to placebo.
This includes achieving at least a 75% improvement from baseline in affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16.
Read more: http://www.pharmatimes.com/news/amgen_looks_to_expand_access_to_otezla_in_the_us_1363892
The submission to the US Food and Drug Administration (FDA) is based on data from the Phase III ADVANCE trial.
In this trial, Otezla (apremilast) 30mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response compared to placebo, at week 16.
In addition, Otezla demonstrated statistically significant improvements in key secondary endpoints compared to placebo.
This includes achieving at least a 75% improvement from baseline in affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16.
Read more: http://www.pharmatimes.com/news/amgen_looks_to_expand_access_to_otezla_in_the_us_1363892
