FDA Approvals Roundup: Nucala, Fetroja, Xeljanz
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New indications
Nucala gets expanded indication for HES
GlaxoSmithKline’s Nucala (mepolizumab injection) has been granted a new indication for the treatment of hypereosinophilic syndrome (HES) in adults and children 12 years and older. The indication is for patients who have had HES for six months or longer, with no other identifiable nonblood-related cause of the disease.
HES comprises a group of blood disorders associated with an overproduction of eosinophils, a type of white blood cell. It is a rare condition for which the last therapy approval was 14 years ago.
The biologic therapy was granted orphan drug designation for the current application, which received fast track designation and priority review.
The drug was evaluated in a 32-week, randomized, placebo-controlled trial in 108 patients with HES. Patients received either Nucala or placebo every four weeks and were monitored for HES flare during the treatment period. In all, 28% of Nucala patients had HES flares, compared with 56% of those receiving placebo, for a relative reduction of 50% and an absolute reduction of 28%. Patients receiving Nucala also had a longer time to first HES flare compared with those receiving placebo.
Nucala was previously indicated for children aged 6 years or older with severe asthma and an eosinophilic phenotype, and for adults with eosinophilic granulomatosis with polyangiitis, an autoimmune condition causing blood vessel inflammation also known as Churg-Strauss syndrome.
Fetroja nabs new indication for hospital-acquired/ventilator-associated pneumonias
Shionogi’s Fetroja (cefiderocol injection) has received an expanded indication for treating patients aged 18 years or older who have hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain Gram-negative microorganisms.
Fetroja is also approved for treating complicated urinary tract infections, including pyelonephritis, caused by Gram-negative pathogens patients 18 years or older.
The extended approval of the supplemental new drug application was based on efficacy and safety findings from the Phase 3 APEKS-NP study. Patients in the multinational, double-blind, randomized trial were randomized to receive Fetroja or meropenem. Efficacy findings showed that Fetroja was noninferior to meropenem in 14-day, all-cause mortality (12.4% vs. 12.2%, respectively). Treatment-related adverse events were similar between the two treatment groups.
Xeljanz expanded to include treatment of active polyarticular course juvenile idiopathic arthritis
Pfizer’s Xeljanz (tofacitinib tablet and oral solution) has received approval for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA), a chronic inflammatory disease.
Xeljanz has received previous approvals for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
The current approval was based on findings from a two-phase, Phase 3 study showing that patients with pcJIA who received tofacitinib had a lower occurrence of disease flare compared with those receiving placebo (31% vs, 55%, respectively; P = .0007). Adverse drug events in the study population were similar to those in patients with rheumatoid arthritis.