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Here are some of the top-read FDA approvals covered by Drug Topics® from this year.
Several drug approvals made headlines this year, ranging from novel treatments to exciting new indications for existing drug therapies.
All eyes have been on the Pfizer/BioNTech and Moderna coronavirus disease 2019 (COVID-19) vaccines, both of which were granted emergency use authorization by the FDA in December. In another historic feat, remdesivir (Veklury; Gilead) scored an approval from the agency as the first drug treatment for COVID-19 on October 22. Remdesivir is indicated for use in hospitalized adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms.
Apart from record-breaking COVID-19 approvals, there were plenty of other noteworthy drug approvals from 2020.
Here are some of the top-read FDA approvals covered by Drug Topics® from this year:
10. FDA Approves Oliceridine for Pain Management in Hospitals, Controlled Clinical Settings
Oliceridine (Olinvyk; Trevena Inc), which was approved in August, is an opioid agonist for the management of pain that is severe enough to require intravenous opioid and when alternative treatments are ineffective.
9. FDA Approves New Doses of Dulaglutide
In September, the FDA approved 2 additional doses of dulaglutide (Trulicity; Eli Lilly) for the treatment of type 2 diabetes. Approval of the 3.0 mg and 4.5 mg doses was based on favorable results in regard to A1C and body weight reduction, stemming from the phase 2 AWARD-11 clinical trial comparing the additional doses with 1.5 mg doses in individuals with type 2 diabetes.
8. FDA OKs New Indication for Esketamine Nasal Spray
In August, esketamine (Spravato; Janssen) CIII nasal spray became the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.
7. FDA Approves CBD Treatment for Seizures in Rare Genetic Disease
The FDA approved cannabidiol (CBD) (Epidiolex; Greenwich Biosciences Inc) oral solution for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older.
The latest indication is only the third approval for CBD, and follows the FDA’s recent draft guidance for conducting CBD research to facilitate and support safe and effective study results.
6. FDA OKs First Treatment for Ebola Virus
Regeneron’s Inmazeb became the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients when it was granted approval in October. The monoclonal antibody mixture is composed of atoltivimiab, maftivimab, and odesivimab-ebgn.
5. FDA Approves Mepolizumab for Hypereosinophilic Syndrome
The FDA approved mepolizumab (Nucala; GlaxoSmithKline) as the first biologic treatment for hypereosinophilic syndrome in adult and pediatric patients aged 12 and older.
4. FDA Approves Tofacitinib for Juvenile Idiopathic Arthritis
The FDA approved tofacitinib (Xeljanz; Pfizer) for the treatment of children and adolescents 2 years of age and older with active polyarticular course juvenile idiopathic arthritis, making it the first and only Janus kinase inhibitor approved in the US for this indication.
3. FDA Approves Baloxavir Marboxil for Post-Exposure Prophylaxis of Influenza
Baloxavir marboxil (Xofluza; Genentech) received FDA approval for the prevention of influenza in individuals aged 12 years of age and older following contact with a person infected with the fly, making it the first single-dose influenza medicine approved for post-exposure prophylaxis.
2. FDA Approves Dupilumab for Atopic Dermatitis in Children
In May, dupilumab (Dupixent; Sanofi and Regeneron) received approval for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years old. With this approval, dupilumab is the only biologic medicine approved for this patient population.
1. FDA Approves Ozanimod for Relapsing Multiple Sclerosis
The FDA granted approval to ozanimod (Zeposia; Bristol Myers Squibb) in March for the treatment of relapsing multiple sclerosis. The approval includes indicated uses for clinically isolated syndrome, relapsing-remitting disease, and active secondary disease.