Pediatrics

Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.

If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.

A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.

Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.

The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.

Stelara is the first biologic targeting both cytokines IL-12 and IL-23 and offers a therapeutic option for children six years of age and older living with active psoriatic arthritis, a rare disease.

Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.

The FDA needs more time to assess information submitted by the company.

The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.

Some have expressed concerns about the risk of myocarditis and unknown longer-term side effects.

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent reduced severe asthma attacks and improved lung function in children 6 to 11 years.

Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.

An FDA decision is expected in late 2022.

The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

Azstarys is approved to treat patients 6 years and older.

While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.

Two major drug recalls in the last week include an expanded recall of a widely used blood pressure medication as well as over-the-counter infant ibuprofen.

FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.

Educating pediatricians in their offices, auditing their prescription patterns, and leveraging a shared electronic health record, encourages them to choose more appropriate antibiotics for children with common respiratory infections, according to a study published in the June 12 issue of the Journal of the American Medical Association.

Teenagers who received DTaP (acellular pertussis vaccine) in their first 2 years of life had a 6 times higher risk of contracting pertussis compared with those who received DTwP (whole-cell pertussis vaccine) in their first 2 years of life, according to a study online in Pediatrics.

The American Academy of Pediatrics (AAP) has published a policy statement to provide pediatricians with recommendations for assessing and treating Clostridium difficile infections (CDI) in children.

The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.

Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)

The recent approval by FDA of an adult cancer therapy is 1 example of how children’s cancer research benefits patients of all ages.

FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.

First-trimester exposure to antiepileptic drugs compared with no exposure does not appear to increase the risk of major birth defects, according to a Danish study, published in the May 18 issue of the Journal of the American Medical Association.

Pediatric patients with moderately to severely active ulcerative colitis demonstrated a clinical response with infliximab (Remicade, Centocor Ortho Biotech), according to data from a phase 3 randomized, multicenter, open-label study.