FDA Panel Gives Nod to Teva’s Asthma Biologic

December 10, 2015
Randi Hernandez

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

An FDA panel recommended approval of Teva’s monoclonal antibody, reslizumab.

Teva’s humanized antibody targeting interleukin-5 (IL-5) for the treatment of inadequately controlled asthma got the nod from FDA’s Pulmonary-Allergy Drugs Advisory Committee yesterday, according to a statement from Teva released on Dec. 10, 2015. The medication is specifically for patients with high blood eosinophil levels, despite the use of an inhaled corticosteroid regimen.

The panel voted 11 to 3 in favor of approval for patients 18 and older, but voted unanimously against approval for children ages 12 to 17, citing efficacy and safety concerns. Panelists also pointed out there were too few children studied in clinical trials. Side effects in clinical trials included anaphylaxis, muscle pain and spasms as a result of muscle toxicity, and elevated levels of creatine phosphokinase (CPK) compared with the placebo group.

Reslizumab, a IgG4K monoclonal antibody (mAb), binds to and neutralizes the eosinophil cytokine IL-5, which is thought to be associated with compromised lung function. Other targeted biologic therapies that are currently in late-stage development for asthma include Roche’s lebrikizumab, AstraZeneca’s tralokinumab, and Sanofi and Regeneron's dupilumab. If approved, reslizumab will likely compete with GlaxoSmithKline’s Nucala (mepolizumab) and Genentech/Sanofi’s anti-IgE mAb Xolair (omalizumab), which was approved by FDA in 2003.

Final regulatory action on reslizumab is expected in March 2016.

Source: Teva, FDA