FDA Approvals Roundup: Tarpeyo, Dartisla ODT, Yusimry

RoundupsRoundups | 05 January 2022 |  By 

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

New approvals

Tarpeyo approved for reducing proteinuria in IgA nephropathy

Calliditas Therapeutics’ Tarpeyo (budesonide) delayed release capsules were granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, also known as Berger’s disease, who are at risk of rapid disease progression.

Approval of Tarpeyo was based on results from an ongoing phase 3 randomized, controlled study that showed reduction in proteinuria for adult patients with primary IgA nephropathy who received Tarpeyo 16 mg daily, compared with placebo. At 9 months, patients who received Tarpeyo had an average reduction in urine protein-to-creatinine ratio of 34%, compared with a 5% reduction among patients who received placebo.

As a condition of the accelerated approval, Calliditas Therapeutics must complete the ongoing study to confirm that Tarpeyo slows kidney function decline in patients with IgA nephropathy.

Tarpeyo was granted orphan drug designation for this indication.

Dartisla ODT approved for peptic ulcer

Edenbridge Pharmaceuticals’ Dartisla ODT (glycopyrrolate) orally disintegrating tablets are approved to reduce the symptoms of a peptic ulcer in adults as an adjunct to treatment of peptic ulcer. The anticholinergic drug is not indicated as monotherapy because its effectiveness in peptic ulcer healing has not been established.

Patients who are receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of Dartisla ODT. The drug is not recommended for patients starting treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product, such as tablet strength of 1 mg.

Yusimry gets nod as adalimumab biosimilar

Coherus BioSciences’ Yusimry (adalimumab-aqvh) has been approved as a Humira (adalimumab) biosimilar product, making it the seventh adalimumab biosimilar. Formerly known as CHS-1420, the biosimilar is indicated for treatment of plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. Yusimry is administered by subcutaneous injection.

The approval is based on a data package demonstrating biosimilarity to the reference product, Humira. That package included results from Study CHS-1420-02, which compared Yusimry and Humira among 545 patients with moderate-to-severe chronic plaque psoriasis, and Study CHS-1420-03, which confirmed pharmacokinetic similarity by comparing the relative bioavailability between Yusimry and Humira after a single dose.

Coherus said it is planning a US launch of Yusimry in the second half of 2023 in accordance with an agreement with the Humira manufacturer, AbbVie.

Leqvio okayed as first siRNA treatment for LDL cholesterol

Novartis’ Leqvio (inclisiran) gained approval as the first and only small interfering RNA (siRNA) therapy indicated for lowering low-density lipoprotein (LDL) cholesterol. Leqvio is an adjunct to diet and maximally tolerated statin therapy for adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who need additional lowering of LDL cholesterol. The treatment is approved at a 284 mg dose that is administered subcutaneously. Patients receive an initial dose, a second dose at three months, and continued injections every six months.  

The approval is based on results from three Phase 3 trials (ORION-9, -10, and -11). The trials included 3,457 participants with ASCVD or HeFH and who had elevated LDL cholesterol while receiving statin therapy. At month 17, patients receiving Leqvio had a sustained reduction in LDL cholesterol of up to 52%, compared with placebo.

The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.

In December 2020, the FDA had issued a complete response letter to Novartis outlining concerns about unresolved facility inspection-related conditions related to the Leqvio new drug application. At the time the FDA said these unresolved conditions were delaying them from meeting Leqvio’s Prescription Drug User Fee Act (PDUFA) action date of 23 December 2020.

Adbry given nod for atopic dermatitis

LEO Pharma’s Adbry (tralokinumab-ldrm) gained approval for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or who cannot tolerate those treatments. Adbry is the first approved biologic to bind to and inhibit the IL-13 cytokine. It can be used with or without topical corticosteroids.

The approval was based on safety and efficacy results from the ECZTRA 1, 2, and 3 trials, which included nearly 2,000 adults with moderate-to-severe atopic dermatitis. Researchers in the ECZTRA 3 trial, which evaluated Adbry 300 mg in combination with topical corticosteroids as needed, found that the treatment was effective and well tolerated in patients with moderate-to-severe atopic dermatitis, compared with placebo.

New indication

Injectafer gets the go-ahead for treating iron deficiency anemia in young children

Daiichi Sankyo’ Injectafer has received approval for pediatric patients (at least one year of age) with iron deficiency anemia (IDA) who are intolerant to oral iron who have had an unsatisfactory response with oral iron.

Injectafer was initially approved in 2013 for adults as a 1,500 mg course of treatment.
 
Caplyta okayed for bipolar depression in adults

Intra-Cellular Therapies’s Caplyta (lumateperone) was approved for the treatment of depressive episodes associated with bipolar I or II disorder in adults. The treatment can be given as monotherapy and as adjunctive therapy with lithium or valproate. Caplyta was initially approved to treat schizophrenia in adults in 2019.
 
The latest approval for Caplyta is based on two Phase 3 placebo-controlled studies of adults with biopolar depression. Caplyta 42 mg showed statistically significant improvements in the Montgomery-Asberg Depression Rating scale and clinical global impression of bipolar disorder in each study, compared with placebo.
 
Oxbryta gets new indication for sickle cell disease in children

Global Blood Therapeutics’ Oxbryta (voxelotor) was granted accelerated approval for the treatment of sickle cell disease in children aged 4-11 years old. Previously, the FDA had granted accelerated approval for the drug in sickle cell disease patients aged 12 years and older.
 
The approval of the new indication was based on positive safety and effectiveness data from 45 patients aged 4-11 years old with sickle cell disease in an ongoing phase 2 trial. In the study, 36% of patients achieved a hemoglobin increase of greater than 1 gram per deciliter from the beginning of the trial to week 24.
 
As a condition of accelerated approval, the ongoing trial must be completed to confirm that the hemoglobin increase leads to clinical benefit.
 
Oxbryta was granted breakthrough designation and orphan drug designation.
 
Xarelto gets new indication for preventing, treating blood clots in children

Janssen’s Xarelto (rivaroxaban) was approved for two new pediatric indications. The first indication is the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients under age 18 who have received at least five days of initial parenteral anticoagulant treatment. The second new indication is for thromboprophylaxis in children at least two years old with congenital heart disease who have undergone the Fontan procedure.
 
These new approvals bring Xarelto to 11 approved indications in the US. The latest approvals are based on positive findings in two phase 3 studies – EINSTEIN-Jr. and UNIVERSE. EINSTEIN-Jr. evaluated the use of Xarelto versus standard anticoagulation therapy in 500 children aged birth to 17 years with previously diagnosed acute VTE who had started parenteral anticoagulation therapy. The UNIVERSE trial, which included 112 participants, is the first clinical trial to examine the use of a direct-acting oral anticoagulant (DOAC) for the prevention of VTE in children who had recently undergone the Fontan procedure.
 
Otezla approved for adults with plaque psoriasis of all severities
Amgen’s Otezla (apremilast) is now approved for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, across all severities. Otezla is already approved for three indications: adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis, and adult patients with oral ulcers associated with Behçet's Disease.
 
The latest approval is based on findings from the Phase 3 ADVANCE trial, in which 21.6% of patients with mild to moderate plaque psoriasis who received Otezla 30 mg twice daily achieved the primary endpoint of Static Physician’s Global Assessment response at week 16, compared with just 4.1% of patients receiving placebo. Otezla also demonstrated significant improvements in key symptoms, compared with placebo.
 
Cosentyx gains approval for children and adolescents

Novartis’ Cosentyx (secukinumab) has been approved for the treatment of active enthesitis-related arthritis (ERA) in patients aged 4 years and older, and active juvenile psoriatic arthritis (JPsA) in patients aged 2 years and older.
 
Cosentyx is already approved for moderate-to-severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy, adults with active ankylosing spondylitis, and adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. Cosentyx was originally approved in 2015, according to the label.
 
The latest approvals are based on findings from the Phase 3 JUNIPERA study, which enrolled 86 children and adolescents with a confirmed diagnosis of ERA or JPsA. The primary endpoint was time to flare during the treatment period. In children with JPsA who received Cosentyx, they had a longer time to flare and showed an 85% reduction in the risk of flare, compared with placebo. For patients with ERA who received Cosentyx, they also had a longer time to flare and showed a 53% reduction in risk of flare, compared with placebo.

 

© 2022 Regulatory Affairs Professionals Society.

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