New Drug Approvals in 2021

In 2021, the U.S. Food and Drugs Administration's Center for Drug Evaluation and Research (CDER) approved 51 new "novel" prescription drugs, the third-highest number of novel drugs approved in one year.  In 2018, 58 novel drugs won U.S. FDA approval and last year, 53 were approved. These novel drugs are considered to be "new molecular entities" (NME) or "new therapeutical biological products, " which are drugs with an active ingredient that have never before been approved in the U.S. For the complete FDA report on new drugs of 2021, download their 26-page booklet.

In addition to the CDER approvals, the FDA's Center for Biologics Evaluation and Research approved 13 therapeutic products, including the Pfizer Covid-19 vaccine, Prevnar-20 pneumococal vaccine, and several blood plasma treatments.  Pfizer expects that its COVID-19 vaccine, Comirnaty, will generate $36 billion in sales in 2021, an amount that far exceeds the $20 billion in sales generated by top-selling drug Humira in 2020.

Like in recent years, many of 2021's novel drug approvals (52% in 2021) were for rare or “orphan” diseases (diseases that affect fewer than 200,000 people in the U.S.). Rare diseases with new treatments in 2021 include the autoimmune disease myasthenia gravis, Alagille syndrome, Pompe disease, achondroplasia (dwarfism), Duchenne muscular dystrophy, and others.
Notable approvals of 2021 include the controversial drug Aduhelm for treating alzheimer's, and the once-a-month Cabenuva Kit complete treatment for HIV. A new birth control pill was also introduced, Nextstellis (drospirenone and estetrol). This drug includes estetrol or "E4", a plant-based estrogen.  Also in 2021, Brexafemme was approved as a new treatment option for vaginal yeast infection.

A new fast-acting ADHD drug for kids that does not contain an amphetamine stimulant is now on the market: Qelbree (viloxazine) capsules  were approved for patients aged six to 17. According to Fierce Pharma, the last non-scheduled (non-amphetamine) ADHD medication to win FDA approval was Shire's Intuniv, back in 2009. The migraine market is getting crowded, but Abbvie's Qulipta (ATOGEPANT) was approved last year to help prevent migraine attacks in patients with episodic migraines.  It competes with another "gepant" drug,  Nurtec ODT (RIMEGEPANT).

This chart of all 51 novel drugs is divided into three lists, according to how the drug is administered, with about half administered orally; and more than half of 2021's drugs being injected through infusion or I.V. in a hospital or health care setting. The I.V. drugs include cancer chemotherapy treatments or treatment adjuncts for small cell lung cancer, lymphoma, endometrial cancer, cervical cancer, and diagnostic agents to help detect prostate cancer or ovarian cancer lesions during surgery. 24 of the new drugs are taken orally in pill or capsule form.   

ORALLY ADMINISTERED: by TABLET OR CAPSULE (Livmarli is a solution) (25 total):

INJECTED DRUGS (19 total; most administered in healthcare setting):

ADMINISTERED by I.V. in health care setting (7 total):

For a recap of Ask a Patient's review of 2020's 53 drug approvals, check out https://www.askapatient.com/news/new-drugs-approved-2020.asp
More information on 2021 drug approvals:
Fierce Pharma: https://www.fiercepharma.com/special-report/2021-s-new-drug-approvals

FDA Biologicals: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2021-biological-license-application-approvals FDA 2021 Novel Drugs Booklet: https://www.fda.gov/media/155227/download