New Drug Approvals and New Pediatric Indications

An Update for Pediatric Healthcare Providers

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS

Disclosures

Pediatr Pharm. 2017;23(7) 

In This Article

New Pediatric Labeling

Fluticasone Propionate

In January, the FDA extended the indications for two corticosteroids for asthma. The approval for fluticasone propionate (ArmonAirTM RespiClick®) and the combination of fluticasone propionate and salmeterol (AirDuoTM RespiClick®) were extended to include use in the maintenance treatment of asthma in patients 12 years of age and older.

Budesonide/Formoterol Fumarate Dehydrate

The approval for the combination of budesonide and formoterol (Symbicort® inhalation aerosol) was extended to include patients 6 to 12 years of age with asthma. Safety and efficacy in this population was found to be similar to that observed in older adolescents and adults.

Elvitegravir, Cobicistat, Emtricitabine/Tenofovir

The FDA-approved indication for this combination product (Stribild®) was extended to include pediatric patients with HIV who are 12 years of age and older. Patients must weigh at least 35 kg at the initiation of treatment to ensure appropriate dosing with the strengths of the four components in the currently available tablet. The approval for the drug was based on the results of a 48-week pharmacokinetic, safety, and efficacy study conducted in 50 treatment-naïve patients demonstrating its benefit.

Lurasidone Hydrochloride

The use of lurasidone (Latuda®), an atypical or second generation antipsychotic used in the treatment of schizophrenia or for irritability associated with autistic disorder, was extended to adolescents 13 to 17 years of age. The approval was based on the results of a 6-week, placebo-controlled trial of 326 adolescents with schizophrenia. Earlier clinical studies also support its use in adolescents.[16]

Acetaminophen

The indication for acetaminophen injection (Ofirmev®) was extended to include treatment of pediatric patients from birth to 2 years of age. The decision to extend approval to infants was based on data demonstrating effective treatment of fever and an adverse effect profile similar to that seen in older children.

Lisdexamfetamine

The approval for lisdexamfetamine (Vyvanse®) was extended to children with ADHD 6 years of age and older. The release of a new strawberry-flavored chewable tablet formulation accompanied the announcement. The chewable tablets are available in 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg strengths and may be substituted on a mg-per-mg basis with the capsule formulation.

Tiotropium Bromide

In February, the FDA expanded the indication for tiotropium bromide (Spiriva® Respimat Inhalation Spray) to include long-term maintenance treatment of asthma in patients 6 to 11 years of age. The approval was supported by three clinical trials demonstrating the safety and efficacy of the drug in this age group. Studies in younger children are ongoing.

Fosphenytoin

The FDA approval for fosphenytoin sodium (Cerebyx®) was extended in March to include use in patients from birth to 17 years of age for the treatment of generalized tonic-clonic status epilepticus, the prevention or treatment of seizures occurring during neurosurgery, and as a temporary replacement for oral phenytoin.

Barium Sulfate

The approval for barium sulfate (Liquid E-Z-Paque®) was extended to patients from birth to 17 years of age requiring radiographic examination of the esophagus, stomach, or small bowel.

Moxifloxacin Ophthalmic Solution

Use of moxifloxacin ophthalmic solution (Vigamox®) was extended to infants less than 1 year of age.

Ciprofloxacin and Gatifloxacin Ophthalmic Solutions

The FDA indications for ciprofloxacin and gatifloxacin ophthalmic drops (Ciloxan® and Zymar®) were extended to include treatment of bacterial conjunctivitis in infants 1 month of age and older. These products had previously been approved for pediatric patients over 1 year of age.

Daptomycin

Daptomycin (Cubicin®) was approved for use in children 1 to 17 years of age with complicated skin and skin structure infections (SSSI). Results of a pharmacokinetic, safety, and efficacy study conducted by the manufacturer in children with SSSI were similar to those of studies conducted in adults. Earlier retrospective studies support the efficacy of daptomycin in children, with an estimated clinical success rate of 81% to 93%.[17,18]

Abatacept

Approval for the subcutaneous use of abatacept (Orencia®) was extended to include children 2 years of age and older with severe active polyarticular juvenile idiopathic arthritis, in combination with methotrexate. The safety and efficacy of the auto-injector device or intravenous administration have not yet been established in children.

Iodixanol

In April, the approval of iodixanol 320 mgI/mL (VisipaqueTM) was extended to include use for coronary computed tomography angiography in children 12 years of age and older.

Ledipasvir and Sofosbuvir

Approval for the combination of ledipasvir and sofosbuvir (Harvoni®) was extended to include pediatric patients 12 years of age and older weighing at least 35 kg. This product is indicated for the treatment of chronic hepatitis C virus genotypes 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.

Sofosbuvir

Sofosbuvir (Sovaldi®) was approved for use in combination with ritonavir for the treatment of children with chronic hepatitis C virus genotypes 2 or 3 infection who are 12 years of age and older and weigh at least 35 kg. It is approved for patients without cirrhosis or with compensated cirrhosis. The weight restriction for both Harvoni® and Sovaldi® reflects the lowest point at which the currently available adult dosage formulations will provide an appropriate dose.

Cetirizine Ophthalmic Solution

The approval for cetirizine eye drops (ZerviateTM) was extended on May 5, 2017 to include children 2 years of age and older for the treatment of ocular itching related to an allergic reaction.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....