Regulatory Focus™ > News Articles > 2021 > 9 > FDA Approvals Roundup: Skytrofa, Invega Hafyera, Briviact

FDA Approvals Roundup: Skytrofa, Invega Hafyera, Briviact

Posted 01 September 2021 | By Renee Matthews 

FDA Approvals Roundup: Skytrofa, Invega Hafyera, Briviact

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

New approvals
Skytrofa approved as weekly therapy for children with growth hormone deficiency
Ascendis’s  Skytrofa (lonapegsomatropin-tcgd injection) has been approved as a weekly human growth hormone treatment for children aged 1 year or older who have short stature because of growth hormone deficiency.
The approval was based on efficacy findings from a 52-week, Phase 3, multicenter, randomized, open-label, active-controlled trial in 161 children with previously untreated growth hormone deficiency. Patients were randomized to receive weekly Skytrofa or daily Genotropin (somatropin). After 52 weeks, patients receiving the study drug had an annual growth rate increase of 11.2 cm versus 10.3 cm in patients receiving Genotropin, demonstrating its noninferiority to Genotropin.
New indications
Invega Hafyera approved as twice-yearly treatment for adults with schizophrenia
Janssen’s Invega Hafyera (6-month paliperidone palmitate injection) has been approved as a twice-yearly treatment for schizophrenia in adults.
Patients receiving the long-acting atypical antipsychotic must first have been treated with Invega Sustenna, 1-month regimen of paliperidone palmitate, for at least 4 months, or Invega Trinza, a 3-month regimen, for at least one 3-month cycle. Invega Sustenna was approved in 2009 and Invega Trinza, in 2015.
Approval of Invega Hafyera was based on findings from a 12-month, Phase 3, randomized, double-blind, noninferiority study in 702 adults from the indicated population. The primary endpoint was time to first relapse at the end of the study period. Results showed noninferiority between Invega Hafyera and Invega Trinza, 92.5% and 92% of patients, respectively, remaining relapse-free at 12 months.
Briviact gets expanded indication for partial-onset seizures in children, infants
UCB’s Briviact (brivaracetam CV tablets, oral solution, injection) has been granted a new indication as monotherapy or adjunctive therapy for treating partial-onset seizures in children aged 1 month or older.
Safety and effectiveness of Briviact have been established in children in the indicated age group and the findings are supported by evidence from studies in adults with partial-onset seizures, according to the FDA drug label. Findings also showed long-term retention rates, with 71.4% and 64.3% of children remaining on treatment with Briviact at 1 and 2 years, respectively.
Briviact was approved in 2016 as an add-on therapy for adults and a monotherapy for in 2017. In 2018, it received approval as monotherapy or adjunctive therapy in children aged 4 years or older.
Tibsovo handed new indication for advanced or metastatic cholangiocarcinoma
Servier’s Tibsovo (ivosidenib) has received a new indication for use in previously treated, locally advanced or metastatic cholangiocarcinoma in adults with an isocitrate dehydrogenase-1 (IDH1) mutation, as detected by the Oncomine Dx Target Test (Life Technologies), which was concurrently approved as a companion diagnostic.
Approval of Tibsovo was based on findings from the multicenter, randomized, double-blind, placebo-controlled Study AG120-C-005 in 185 previously treated adults randomized to receive Tibsovo or placebo until disease progression or unacceptable toxicity. Primary endpoint was progression-free survival (PFS). Findings showed a statistically significant improvement in PFS for patients receiving Tibsovo (hazard ratio, 0.37; 95% confidence interval, 0.25-0.54; P < .0001). Overall survival was not significant (HR, 0.79; 95% CI, 0.56-1.12; P = .093); 70% of patients randomized to placebo crossed over to Tibsovo after radiographic disease progression.
The application was granted priority review and fast track and orphan product designations. The review used the assessment aid.
Tibsovo was originally approved in 2018 for treating acute myeloid leukemia.



© 2021 Regulatory Affairs Professionals Society.

Tags: FDA, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.