Drug Pipeline News

A supplemental New Drug Application for empagliflozin (Jardiance; Boehringer Ingelheim and Eli Lilly and Company) in pediatric patients with type 2 diabetes has been accepted by the FDA.

Following positive results from a phase 3 clinical trial, the FDA has accepted a New Drug Application for berdazimer gel, 10.3% (Novan) for treating patients with molluscum contagiosum.

A supplemental Biologics License Application has been accepted by the FDA for treating adolescents and adults with chronic spontaneous urticaria.

Velmanase alfa-tycv (Lamzede, Chiesi Global Rare Diseases) has received approval by the FDA for treating alpha-mannosidosis in adult and pediatric patients.

Omaveloxolone (SKYCLARYS, Reata Pharmaceuticals) has received FDA approval for treating Friedreich’s ataxia in patients aged 16 years and older.

The wearable device received its original FDA go-ahead in 2019, and has since demonstrated effectiveness in preventive and acute care for migraine treatment in adolescents and adults.

A new drug application for VP-102 for treating molluscum contagiosum has been accepted by the FDA.

Previously known as efanesoctocog alfa, once-weekly ALTUVIIIO is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes for adults and children with hemophilia A.

A New Drug Application has been submitted to the FDA for potential approval of roflumilast foam 0.3% for the treatment of seborrheic dermatitis in adults and adolescents.

The federal agency set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

Read the latest medications for pediatric patients approved by the US Food and Drug Administration.

Linaclotide (LINZESS; Ironwood Pharmaceuticals) has been granted Priority Review by the US Food and Drug Administration for treating pediatric patients with functional constipation.

Aflibercept is now approved to treat 5 retinal conditions caused by ocular angiogenesis.

In a recent statement, the US Food and Drug Administration warned pharmacies and health care providers about unsafe aluminum levels for pediatric patients in Hospira’s unapproved potassium phosphates drug product.

A supplemental New Drug Application (sNDA) for abrocitinib (CIBINQO; Pfizer) in adolescents has been approved by the US Food and Drug Administration.

Lanadelumac (TAKHZYRO; Takeda) has received an approval for a supplemental Biologics License Application to prevent hereditary angioedema attacks in pediatric patients aged 2 years and older.

The US Food and Drug Administration has approved the use of a pre-filled tezepelumab (TEZSPIRE; Amgen and AstraZeneca) pen in patients aged 12 years and older with severe asthma.

Odactra (House Dust Mite Allergen Extract; ALK) has received approval from the US Food and Drug Administration for use in patients aged 12 to 17 years with house dust mite-induced allergic rhinitis.

After addressing a 2021 CRL, Verrica Pharmaceuticals vies for the agent to become the first drug approved to treat the common skin infection.

Orphagen Pharmaceuticals has announced their drug OR-499 received a rare pediatric disease designation for treating pediatric adrenocortical carcinoma from the US Food and Drug Administration.

A phase 3 trial of lomitapide showed safety and efficacy for treating homozygous familial hypercholesterolemia (HoFH) in pediatric patients aged 5 to 17 years.

The US Food Administration has agreed to review an application for nirsevimab (Beyfortus; AstraZeneca and Sanofi) to protect infants against RSV.

Novo Nordisk has announced their product Wegovy received approval from the US Food and Drug Administration for use in adolescents aged 12 years and older with obesity.

Arcutis Biotherapeutics, Inc has submitted a supplemental New Drug Application for roflumilast cream (ZORYVE) to the US Food and Drug Administration for treatment of plaque psoriasis in children aged 2 to 11 years.

If approved, according to AbbVie, linaclotide would be the first prescription therapy for FC in this patient population.

The FDA has approved atezolizumab for use in patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.

Boehringer Ingelheim and Eli Lilly have announced positive results from a phase 3 trial for Jardiance in reducing blood sugar levels in children with type 2 diabetes.

The US FDA announced the approval of teplizumab (Tzield), which is administered through IV infusion once daily for 14 consecutive days, for delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Recently announced data from the INTEGUMENT-1 phase 3 clinical trial demonstrated positive safety and efficacy results for atopic dermatitis patients 6 years and older treated with roflumilast cream (Arcutis Biotherapeutics).

At ACR Convergence 2022, Amit Golding, MD, PhD, outlined drugs recently approved by the FDA, and discussed the requirements for biosimilars to meet approval.