Drug Pipeline

FDA Approves Secukinumab Label Update for Dosing Flexibility in AS

The FDA has approved a label update for secukinumab, allowing the option for a higher 300 mg dose among adults with active ankylosing spondylitis based on clinical response.

The expanded label for secukinumab (Cosentyx, Novartis) was previously approved by the European Commission in October 2019.

“This approval gives clinicians added flexibility to ensure patients are able to achieve the best response to treatment and experience full relief from the signs and symptoms of AS,” Todd Fox, global head of medical affairs immunology, hepatology and dermatology at Novartis, said in a press release. “It’s further encouraging news in our efforts to reimagine medicine across the [axial spondyloarthritis] disease spectrum.”

The FDA based its approval on data from the MEASURE 3 trial, which demonstrated that a 300 mg dose of secukinumab sustained improvements in the signs and symptoms of active AS over 3 years without increasing the incidence of adverse events compared with a 150 mg dose.

 
The FDA has approved a label update for secukinumab, allowing the option for a higher 300 mg dose among adults with active AS based on clinical response.
Source: Adobe

Additionally, the MEASURE 3 trial showed that response rates with more stringent clinical endpoints, including ASAS40, were greater in the 300 mg dose group, particularly among patients with previous anti-TNF exposure. By the end of the study, 56.5% of patients assigned to the 300 mg dose achieved ASAS40 vs. 47.7% of patients assigned to the 150 mg dose.

The FDA has approved a label update for secukinumab, allowing the option for a higher 300 mg dose among adults with active ankylosing spondylitis based on clinical response.

The expanded label for secukinumab (Cosentyx, Novartis) was previously approved by the European Commission in October 2019.

“This approval gives clinicians added flexibility to ensure patients are able to achieve the best response to treatment and experience full relief from the signs and symptoms of AS,” Todd Fox, global head of medical affairs immunology, hepatology and dermatology at Novartis, said in a press release. “It’s further encouraging news in our efforts to reimagine medicine across the [axial spondyloarthritis] disease spectrum.”

The FDA based its approval on data from the MEASURE 3 trial, which demonstrated that a 300 mg dose of secukinumab sustained improvements in the signs and symptoms of active AS over 3 years without increasing the incidence of adverse events compared with a 150 mg dose.

 
The FDA has approved a label update for secukinumab, allowing the option for a higher 300 mg dose among adults with active AS based on clinical response.
Source: Adobe

Additionally, the MEASURE 3 trial showed that response rates with more stringent clinical endpoints, including ASAS40, were greater in the 300 mg dose group, particularly among patients with previous anti-TNF exposure. By the end of the study, 56.5% of patients assigned to the 300 mg dose achieved ASAS40 vs. 47.7% of patients assigned to the 150 mg dose.