FDA Approvals Roundup: Qulipta, Repatha, Erbitux

| 29 September 2021 | By Renee Matthews 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Qulipta approved as preventive treatment of migraine
AbbVie’s Qulipta (atogepant tablets) has been approved for the preventive treatment of episodic migraine in adults.
The approval of Qulipta was based on findings from the Phase 3 ADVANCE study, a Phase 2/3 efficacy, safety, and tolerability study, and a Phase 3 long-term safety study.
In the pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, 910 patients in the indicated population were randomized 1:1:1:1 to receive Qulipta at 10, 30, or 60 mg, or placebo. Number of migraine days at baseline ranged from 7.5 to 7.9 days across the four groups. Changes in the number of migraine days from baseline to 12 weeks for patients receiving 10, 30, or 60 mg were -3.7 days,  -3.9 days, and -4.2 days, respectively, compared with -2.5 days for placebo.
Findings also supported a secondary endpoint measuring the proportion of patients who had a 50% or greater reduction in monthly migraine days across the 12-week period. They showed that 56%, 59%, and 61% of patients receiving 10 mg, 30 mg, or 60 mg Qulipta, respectively, achieved a 50%-100% reduction, compared with 29% of placebo patients.
New indications
Repatha use extended for adolescents with rare forms of high cholesterol
Amgen’s Repatha (evolocumab injection) has received a new indication as an add-on treatment to diet, with or without other therapies, for patients aged 10 years or older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH).
HoFH and HeFH are rare, life-threatening genetic conditions in which patients have extremely high levels of low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol. Repatha acts to reduce those high levels.
The new indication was supported by findings in a study of adolescent patients with HeFH who received monthly Repatha injections for 24 weeks or placebo. Those receiving Repatha had an average 38% reduction in LDL-C compared with placebo patients. Another study, also in adolescents, but with HoFH, showed that those receiving monthly Repatha for 80 weeks had an average 14% reduction in LDL-C compared with baseline.
Repatha was first approved in 2015 to reduce the risk of certain complications of cardiovascular disease in adults, and as an add-on therapy to reduce LDL-C cholesterol levels in adults with HeFH and patients with HoFH in patients aged 13 years and older.
Erbitux gets new indication for BRAF-V600E mutated, previously treated metastatic CRC
Eli Lilly’s Erbitux (cetuximab injection) has been granted a new indication, in combination with Pfizer’s Braftovi (encorafenib), for use in previously treated adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
The new indication was supported by findings from the Phase 3, multicenter, randomized, open-label, 3-arm BEACON CRC trial in patients from the indicated population who received the Erbitux-Braftovi combination (n = 220) or Erbitux with either irinotecan or FOLFIRI (n = 221; control arm) until disease progression or unacceptable toxicity. Median overall survival was 8.4 months in Erbitux-Braftovi patients and 5.4 months for the control arm. Objective response rate was 20% and 2%, respectively; median progression-free survival, 4.2 months and 1.5 months.
Erbitux was first approved in 2004 and is also used to treat head and neck cancer.


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