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Regulatory Focus™ > News Articles > 2022 > 5 > FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay

FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay

Posted 04 May 2022 | By Renee Matthews 

FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay

New approvals 

Camzyos gets go-ahead for adults with obstructive hypertrophic cardiomyopathy 

Bristol Myers Squibb’s Camzyos (mavacamten; capsules) has been approved for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. 

 

The approval of Camzyos was based on findings from the Phase 3 double-blind, placebo-controlled EXPLORER-HCM trial 251 adults from the indicated population who were randomized 1:1 to receive  daily Camzyos or placebo. The primary composite functional endpoint, assessed at 30 weeks, was the proportion of patients achieving improvement of mixed venous oxygen tension and improvementIt’s in NYHA class and no worsening in NYHA class. In all, 37% of patients in the Camzyos group met the primary endpoint, compared with 17% in the placebo group. At week 30, patients receiving Camzyos had greater improvement compared to patients on placebo across all secondary endpoints, which included left ventricular outflow tract obstruction, functional capacity, and health status. 

 

Camzyos, a cardiac myosin inhibitor, comes with a boxed warning for risk of heart failure and is available only through the risk evaluation and mitigation strategy. 

 

Vivjoa approved for sustained reduction of chronic yeast infection 

Mycovia’s Vivjoa (oteseconazole; capsules) has been approved for sustained reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in women with a history of the condition who are not of reproductive potential. 

 

The approval of Vivjoa, an azole antifungal, was based on findings from three Phase 3 trials, the global VIOLET studies (438 and 425 patients) and the US-focused ultraVIOLET study in 219 patients.   

 

In the VIOLET studies, 93.3% and 96.1% of women who received Vivjoa did not have a recurrence for the 48-week maintenance period, compared with 57.2% and 60.6% of patients receiving placebo. In the ultraVIOLET study, 89.7% of women who received Vivjoa cleared their initial yeast infection and did not have a recurrence for the 50-week maintenance period, compared with 57.1% of those receiving fluconazole plus placebo. 

 

Epsolay okayed for treating inflammatory lesions in rosacea 

Sol-Gel’s Epsolay (benzoyl peroxide, cream) has been approved for treating inflammatory lesions in adults with rosacea. The topical oxidizing agent was approved through the 505(b)(2) pathway, which allows drugs to be approved based in part on data from studies conducted by other parties. 

 

The approval was supported by data from two positive, identical Phase 3, randomized, double-blind, multicenter clinical trials in which 733 patients from the indicated population received Epsolay or vehicle cream. At 12 weeks, inflammatory lesions in patients receiving Epsolay were reduced by almost 70% from baseline, compared with 38%-46% of vehicle patients. Almost half of the study drug patients were clear or almost clear of lesions at 12 weeks.    

 

Sol-Gel has granted Galderma exclusive rights to commercialize Epsolay in the US. 

 

New indications 

Qelbree use extended to adults with ADHD 

Supernus’s Qelbree (viloxazine; extended-release capsules) has been granted a new indication for treating attention deficit hyperactivity disorder (ADHD) in adults aged 18 or older. 

 

The therapy was originally approved in 2021 for treating ADHD in pediatric patients aged between 6 and 17 years based on data from three studies in children. 

 

The current supplemental approval of Qelbree for adults was based on findings in a short-term Phase 3, double-blind, placebo-controlled, flexible-dose study in 374 patients from the indicated population who were randomized to receive daily Qelbree or placebo. The primary endpoint was change (reduction) from baseline in the ADHD Investigator Symptom Rating Scale. At 6 weeks from baseline, patients treated with Qelbree showed a least-squares mean reduction of -15.5 in the AISRS score, compared with -11.7 in placebo patients.  

 

Qelbree, a selective norepinephrine reuptake inhibitor, comes with a boxed warning for suicidal thoughts and behaviors. 

 

Rinvoq nabs new indication for adults with active ankylosing spondylitis 

AbbVie’s Rinvoq (upadacitinib; tablets) has been granted a new indication for treating adults with active ankylosing spondylitis with an inadequate response or intolerance to any of the tumor necrosis factor (TNF) blockers. 

 

Approval of Rinvoq, a selective JAK inhibitor, was based on findings from the SELECT-AXIS 1 and SELECT-AXIS 2 trials. In both pivotal trials, more patients receiving Rinvoq achieved an ASAS40* response (51% and 44.5%, respectively) at week 14, compared with those receiving placebo (26% and 18.2%). 

 

Rinvoq was originally approved in 2019 for adults with moderate to severe rheumatoid arthritis and is also approved for adults with active psoriatic arthritis. It comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. 

 

Veklury now approved for COVID-19 in children aged 1 month or older 

Gilead’s Veklury (remdesivir; injection) has been granted a new indication for treating pediatric patients older than 28 days, weigh at least 3 kg, and are hospitalized with COVID-19 or have mild-to-moderate disease and deemed high risk for progression to severe COVID-19. 

 

The approval was supported by findings in the CARAVAN Phase 2/3 single arm, open-label study, which demonstrated that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.  

 

Veklury was originally approved in 2020 for adults and pediatric patients aged 12 years or older and weighing at least 40 kg for treating COVID-19 requiring hospitalization. 

 

 

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