In 2022, the Food and Drug Administration (FDA) approved 37 new drugs for a wide range of medical conditions, including cancer, dermatological disorders, rare diseases, and autoimmune disorders. These approvals represent significant advancements in medical research and demonstrate the continued progress being made in the fight against disease. In this article, we will list the 37 FDA-approved drugs released and take a closer look at some of the most notable drugs that were approved in 2022, highlighting their potential benefits and the conditions they treat.
FDA-Approved Drugs for Oncology:
One of the most notable areas of drug development in 2022 was cancer treatments. Several new drugs were approved for the treatment of various types of cancer, including:
- Lunsumio (mosunetuzumab): is a medication used to treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkins lymphoma. It works by targeting specific proteins on the surface of cancer cells and triggering the immune system to attack and destroy them.
- Rezlidhia (olutasidenib): is a medication used to treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. It works by inhibiting the activity of the mutated IDH1 enzyme, which is involved in the development and progression of cancer cells.
- Kimmtrak (tebentafusp): is a medication used to treat unresectable or metastatic uveal melanoma, a rare and aggressive form of eye cancer. It works by targeting a specific protein, gp100, that is found on the surface of melanoma cells, triggering an immune response that leads to the destruction of cancer cells. Kimmtrak is a type of immunotherapy known as a bispecific T cell engager (BiTE), which binds to both cancer cells and immune cells, bringing them together and enabling the immune system to recognize and attack the cancer cells. Kimmtrak is the first and only drug approved for the treatment of uveal melanoma, and it represents a promising new option for patients with this difficult-to-treat disease.
FDA-Approved Drugs for Dermatology:
Another area of notable drug development in 2022 was dermatology. Several new drugs were approved for the treatment of various dermatological disorders, including:
- NexoBrid (anacaulase): is a medication used to remove eschar in adults with deep partial thickness or full thickness thermal burns. It works by breaking down the dead tissue in the wound, making it easier to remove and allow new healthy tissue to grow.
- Sotyktu (deucravacitinib): is a medication used to treat moderate-to-severe plaque psoriasis, a chronic autoimmune skin condition characterized by raised, red, and scaly patches on the skin. It works by blocking specific proteins involved in the immune response that leads to inflammation and skin cell overgrowth.
- Spevigo (spesolimab): is a drug used to treat generalized pustular psoriasis flares, a severe and potentially life-threatening form of psoriasis characterized by widespread pus-filled blisters on the skin. It works by blocking specific proteins involved in the immune response that lead to inflammation and skin cell overgrowth.
FDA-Approved Drugs for Rare Diseases and Autoimmune Disorders:
Notable drug development in 2022 also focused on treatments for rare diseases and autoimmune disorders. Several new drugs were approved for the treatment of various rare diseases and autoimmune disorders, including:
- Briumvi (ublituximab-xiiy): is a drug used to treat relapsing forms of multiple sclerosis, a chronic autoimmune disorder that affects the central nervous system. It works by targeting and destroying certain white blood cells in the body that attack the myelin sheath surrounding nerve fibers, leading to improved symptoms and reduced disease activity.
- Sunlenca (lenacapavir): is a drug used to treat adults with HIV (human immunodeficiency virus) whose infections cannot be successfully managed with other available treatments due to resistance, intolerance, or safety considerations. It works by blocking the ability of the virus to replicate and spread in the body, leading to reduced viral load and improved immune function.
- Amvuttra (vutrisiran): is a medication used to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis, a rare genetic disorder that causes the buildup of abnormal proteins in the nerves and organs. It works by reducing the production of abnormal protein, leading to improved symptoms and a decrease in disease progression.
- Ztalmy (ganaxolone): is a medication used to treat seizures in cyclin-dependent kinase-like 5 deficiency disorder, a rare genetic disorder that affects the brain and causes developmental delays and seizures. It works by enhancing the activity of certain neurotransmitters in the brain that regulate seizures.
Full List of FDA-Approved Drugs in 2022
View the list of FDA-approved drugs in 2022 below from www.fda.gov. To see the FDA-approved conditions of use, such as indications, populations, and dosing regimens for each of these products, see the most recent FDA-approved prescribing information by clicking on the drug name.
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 37. | NexoBrid | anacaulase-bcdb | 12/28/2022 | To remove eschar in adults with deep partial thickness or full thickness thermal burns |
| 36. | Briumvi | ublituximab-xiiy | 12/28/2022 | To treat relapsing forms of multiple sclerosis |
| 35. | Xenoview | hyperpolarized Xe-129 | 12/23/2022 | To evaluate pulmonary function and imaging |
| 34. | Lunsumio | mosunetuzumab-axgb | 12/22/2022 | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkins lymphoma |
| 33. | Sunlenca | lenacapavir | 12/22/2022 | To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations |
| 32. | Krazati | adagrasib | 12/12/2022 | To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy |
| 31. | Rezlidhia | olutasidenib | 12/1/2022 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation |
| 30. | Tzield | teplizumab-mzwv | 11/18/22 | To delay the onset of stage 3 type 1 diabetes |
| 29. | Elahere | mirvetuximab soravtansine-gynx | 11/14/2022 | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy |
| 28. | Tecvayli | teclistamab-cqyv | 10/25/2022 | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy |
| 27. | Imjudo | tremelimumab | 10/21/2022 | To treat unresectable hepatocellular carcinoma |
| 26. | Lytgobi | futibatinib | 9/30/2022 | To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements |
| 25. | Relyvrio | sodium phenylbutyrate/taurursodiol | 9/29/2022 | To treat amyotrophic lateral sclerosis (ALS) |
| 24. | Omlonti | oomidenepag isopropyl ophthalmic solution | 9/22/2022 | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension |
| 23. | Elucirem | gadopiclenol | 9/21/2022 | To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body |
| 22. | Terlivaz | terlipressin | 9/14/2022 | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function |
| 21. | Rolvedon | eflapegrastim | 9/9/2022 | To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia |
| 20. | Sotyktu | deucravacitinib | 9/9/2022 | To treat moderate-to-severe plaque psoriasis |
| 19. | Daxxify | daxibotulinumtoixnA-lanm | 9/7/2022 | To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity |
| 18. | Spevigo | spesolimab-sbzo | 9/1/2022 | To treat generalized pustular psoriasis flares |
| 17. | Xenpozyme | Olipudase alfa | 8/31/2022 | To treat Acid Sphingomyelinase Deficiency |
| 16. | Amvuttra | vutrisiran | 6/13/2022 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 15. | Vtama | tapinarof | 5/23/2022 | To treat plaque psoriasis |
| 14. | Mounjaro | tirzepatide | 5/13/2022 | To improve blood sugar control in diabetic patients, in addition to diet and exercise |
| 13. | Voquezna | vonoprazan, amoxicillin, and clarithromycin | 5/3/2022 | To treat Helicobacter pylori infection |
| 12. | Camzyos | mavacamten | 4/28/2022 | To treat certain classes of obstructive hypertrophic cardiomyopathy |
| 11. | Vivjoa | oteseconazole | 4/26/2022 | To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential |
| 10. | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | 3/23/2022 | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies |
| 9. | Opdualag | nivolumab and relatlimab-rmbw | 3/18/2022 | To treat unresectable or metastatic melanoma |
| 8. | Ztalmy | ganaxolone | 3/18/2022 | To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder |
| 7. | Vonjo | pacritinib | 2/28/2022 | To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets |
| 6. | Pyrukynd | mitapivat | 2/17/2022 | To treat hemolytic anemia in pyruvate kinase deficiency |
| 5. | Enjaymo | sutimlimab-jome | 2/4/2022 | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease |
| 4. | Vabysmo | faricimab-svoa | 1/28/2022 | To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema |
| 3. | Kimmtrak | tebentafusp-tebn | 1/25/2022 | To treat unresectable or metastatic uveal melanoma |
| 2. | Cibinqo | abrocitinib | 1/14/2022 | To treat refractory, moderate-to-severe atopic dermatitis |
| 1. | Quviviq | daridorexant | 1/7/2022 | To treat insomnia |
Conclusion
The 37 new drugs that were approved by the FDA in 2022 represent significant advancements in medical research and demonstrate the continued progress being made in the fight against disease. These drugs are providing new treatment options for a wide range of medical conditions, including cancer, dermatology, rare diseases, and autoimmune disorders. They offer hope to patients who previously had limited treatment options, and have the potential to significantly improve patient outcomes and quality of life.
As medical research continues to advance, we can expect to see even more breakthroughs in the coming years. However, it is important to note that these drugs may not be suitable for everyone and should only be taken under the guidance of a healthcare professional. As with all new treatments, it is crucial to continue researching and monitoring the long-term effects of these drugs to ensure their safety and efficacy. Overall, the 37 novel drugs approved by the FDA in 2022 are a testament to the power of medical innovation and the dedication of researchers and healthcare professionals to improving the lives of patients.
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