Regulatory Focus™ > News Articles > 2021 > 10 > Approvals Roundup: Xipere, Seglentis, Dupixent

Approvals Roundup: Xipere, Seglentis, Dupixent

Posted 27 October 2021 | By Renee Matthews 

Approvals Roundup: Xipere, Seglentis, Dupixent

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Xipere okayed for uveitis-associated macular edema
Clearside’s  Xipere (triamcinolone acetonide injectable suspension) has been approved for use in the  suprachoroidal space of the eye to treat macular edema associated with non-infectious uveitis.
 
The approval of the corticosteroid was based on findings from the Phase 3 randomized, multicenter, double-masked, PEACHTREE clinical trial of 160 patients from the indicated population. The primary efficacy endpoint was improvement of at least 15 letters from baseline in best corrected visual acuity (BCVA). At week 24, 47% of patients receiving Xipere showed improvement in BCVA, compared with 16% of those in the control arm, who were treated with sham suprachoroidal injections.
 
Seglentis gets go-ahead for acute pain in adults
Esteve’s Seglentis (celecoxib and tramadol hydrochloride) has been approved for managing acute pain in adults that requires an opioid analgesic and for which alternative treatments are inadequate.
 
The oral combined opioid agonist and nonsteroidal anti-inflammatory comes with a boxed warning because of the opioid-related risks for addiction, abuse, and misuse.
 
The approval was based on findings from a Phase 3 randomized, double-blind, active- and placebo-controlled clinical trial in 637 patients from the indicated population. Patients were randomized 2:2:2:1 to receive Seglentis, tramadol, celecoxib, or placebo. Mean baseline intensity was 6.7 on the Numeric Pain Rating Scale. Pain intensity difference from baseline over 48 hours was -4.2, -3.9, and -3.6, for Seglentis, both tramadol and celecoxib, and placebo, respectively.
 
Kowa Pharmaceuticals America will market the drug in the US.

New indications
Dupixent nabs expanded indication for children with asthma
Regeneron’s Dupixent (dupilumab) has been granted a new indication as an add-on maintenance treatment for moderate-to-severe asthma in children aged 6 to 11 years with an eosinophilic phenotype or corticosteroid-dependent asthma.
 
Approval of the injectable interleukin-4 receptor alpha antagonist was based on findings from the Phase 3 randomized, double-blind, placebo-controlled LIBERTY ASTHMA VOYAGE trial in 408 children from the indicated population who received Dupixent or placebo, both combined with standard-of-care asthma therapy.
 
Patients with high levels of eosinophils who received add-on Dupixent experienced an average 65% reduction in events over 1 year, compared with those receiving placebo (0.24 vs. 0.67 events a year, respectively). Improved lung function was noted as early as 2 weeks after treatment initiation and sustained for up to 52 weeks, with treated patients showing 5.32% more improvement in predicted forced expiratory volume in 1 second (FEV1)   at 12 weeks compared with their placebo counterparts. At week 24, 81% of treated patients reported a clinically meaningful improvement based on disease symptoms and impact measured on the Asthma Control Questionnaire, compared with 64% of placebo patients.
 
Duxipent was originally approved in 2017 for treating adults with moderate-to-severe atopic dermatitis.
 

 

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Tags: FDA, US

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