The FDA officially released its annual report on new drugs in 2020

2020 Innovation Drug Approval By 2020, CDER has approved a total of 53 innovative drugs, the second-highest total in nearly 20 years after 59 in 2018.
these new drugs are often innovative products that address unseeded medical needs or significantly advance patient care, and their active ingredients have never been approved in the United States before.
"first-in-class" therapy 21 of the 53 innovative drugs are "first-in-class" therapies, accounting for 40% of the total.
the mechanism of these new drugs is different from existing therapies and has the potential to have an important positive impact on public health.
examples given in the report include the HIV treatment Rukobia, developed by ViiV Healthcare.
is a new antiretroviral drug for people with HIV who have tried multiple HIV therapies and have not been successfully treated due to drug resistance, inability or safety.
Fostemsavir is a "first-in-class" HIV attachment inhibitor.
this new drug type can benefit patients who exhaust their existing treatment options.
is the first innovative FDA-approved treatment for neurofibromatosis Type 1 (NF1).
2020, 31 (58%) innovative drugs are approved for the treatment of rare or orphan diseases (defined as diseases that affect less than 200,000 U.S. patients).
, for example, Evrysdi is the first oral treatment approved by the FDA for spinal muscular dystrophy.
Orladeyo (berotralstat) is the first oral nonsteroidal treatment option to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients over 12 years of age.
2020 FDA Approved Innovative Drugs Introduction FDA uses special channels to accelerate drug development and approval to drive innovation In 2020, the FDA uses multiple regulatory channels to enhance the speed and efficiency of innovative drug development and approval.
of the innovative drugs approved in 2020, 32 per cent were fast-tracked, 42 per cent were identified as breakthrough therapies, 57 per cent were eligible for priority review and 23 per cent were approved expedited.
, 36 innovative drugs (68 percent) are at least one of the FDA's four major qualifications.
addition, 92 per cent of the 53 innovative drugs approved in 2020 were approved during the first round of reviews and 75 per cent were first regulatoryly approved in the United States.
information about these drug approvals can be seen in the detailed list below.
fda approved several approved drug expansion adaptations or patient groups last year, in addition to approving innovative therapies.
CDER report also lists important new adaptation approvals for 2020, many of which reached the "first" milestone.
, for example, in December, the FDA approved Belysta (belimumab) extended adaptation for the treatment of active lupus nephritis (LN) adult patients undergoing standard therapies.
lupus nephritis is a severe inflammation of the kidneys caused by systemic lupus erythematosus (SLE), which can lead to end-stage kidney disease and require dialysis or kidney transplantation.
is the first FDA-approved treatment for lupus nephritis.
THE FDA approved AstraZeneca's SGLT2 in 2020 to suppress Dapagliflozin, an English-language product known as Farxiga, for the treatment of adult patients with reduced shot blood scores to reduce the risk of cardiovascular death and hospitalization for heart failure.
is the first SGLT2 inhibitor approved to treat this group of patients with heart failure.
PD-1 inhibitor Keytruda was approved in 2020 for first-line treatment for patients with non-removable or metastatic microsatellital instability (MSI-H) or misalmetric repair defects (dMMR) colorectal cancer.
is the first first first line of immunotherapy for this patient type that does not include chemotherapy.
novartis subcute injection CD20 antibody Kesimpta (ofatumumab, ofofatomu monoanti) has been approved for the treatment of adult multiple sclerosis (RMS) patients with multiple hairstyles.
is the first B-cell targeted therapy that patients can self-dos with in their own homes.
GlaxoSmithKline (GSK)'s IL-5 monoclonal antibody Nucala (mepolizumab) has been approved for the treatment of eosinophilia (HES) patients in adults and children over 12 years of age.
the first FDA-approved new treatment in nearly 14 years for this group of patients.
's heavy PD-L1 inhibitor Tecentriq was approved in 2020 to work with Avastin to treat patients with advanced liver cancer.
is the first treatment to improve total patient survival and progress-free survival in more than a decade compared to previous standard therapies.
biosimilar, approved by the FDA for biosimilars, is very similar to innovative biologics approved by the FDA and has no clinical difference in safety, purity or pot.
2020, the FDA approved three new biosynthic drugs: the CD20 antibody Ritham biosynthic ribni (rituximab-arrx) and the TNF antibody Humira biosynthic drug The biosynthic drug Nyvepria (pegfilgrastim-apgf) of Hulio (adalimumab-fkjp) and recombinant granulocyte activation stimulation factor (GCSF) similarity Neulasta.
so far, the FDA has approved 29 biosychable drugs, including the best-selling biologics Humira, Rituxan, Enbrel, Herceptin, Avastin, Remicade, and Neulasta, providing patients with at least one approved biosychic drug, providing patients with more treatment options.
CDER report also describes the new formulation approved in 2020 and the new Dosage Forms.
are not short of drugs that have a significant impact on patient health.
, for example, the FDA's CD38 monoclonal antibody Darzalex Faspro (daratumumab and recombinant human hyalurase) approved last year is the first CD38 monoclonal antibody approved for subsurfaced injections.
can be reduced from a few hours to a few minutes compared to intravenous infusion.
the FDA faces serious challenges from COVID-19 in 2020, the FDA uses a variety of tools to accelerate drug development and review to get more new drugs to market early, according to the report.
more important than the number of new drugs on the market is the medical value they bring.
they can further benefit more patients.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
: s1. New Drug Therapy Approval. Retrieved January 12, 2021, from