Novel Drug Approvals for 2023
In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) hit a significant milestone, approving 55 new drugs, an increase of nearly 50% from last year and second only to the all-time high of 2018 . This number highlights the innovative trend in the pharmaceutical field and demonstrates the industry’s great success in different treatment areas. What is particularly eye-catching is that among the new drugs approved by the FDA in 2023, antibody drugs occupy a prominent position, including China’s domestic PD-1 monoclonal antibodies, which brings new hope to the medical community.
Among these 55 new drugs, oncology once again became the most approved treatment area, fully reflecting the medical community’s in-depth research on cancer treatment. At the same time, the fields of neurology and infectious diseases have also been recognized by the FDA, providing more treatment options for patients. The emergence of new drugs will promote the rapid development of medical technology and further promote progress in the health field.
It is worth mentioning that 2023 has also become a year of significant progress in the field of rare diseases, providing patients with new treatment options. Pfizer performed well this year. Not only did it become the company with the most approvals, it also launched a number of highly anticipated new products, covering multiple disease fields such as tumors, immunity, infection, and the nervous system.
In this dynamic year of medical innovation, it is worth noting that there are 6 new drugs that belong to the peptide drug category. They are:
1.Daybue (Trofinetide, Trofinetide)
- Developer: Acadia Pharmaceuticals
- Approval time: 2023-03-10
- Indications: Rett syndrome
- Delivery method: Oral solution (200 mg/ml), specific dosage is based on body weight
- Introduction: It is used to treat Rett syndrome and is the first approved therapy for Rett syndrome. It exerts neuroprotective effects by enhancing synaptic activity and restoring synaptic structure.
2.Rezzayo (Rezafungin, Rezafungin)
- Developer: Melinta Therapeutics/Cidara Therapeutics
- Approval time: 2023-03-22
- Indications: Candidemia and invasive candidiasis
- Delivery method: Intravenous injection (200 mg once weekly)
- Introduction: For the treatment of candidemia and invasive candidiasis, it is the first new treatment option approved for this indication in more than a decade.
3.Paxlovid (nirmatrelvir&ritonavir)
- Developer: Pfizer
- Approval time: 2023-05-25
- Indications: Covid-19
- Mode of delivery: Oral
- Introduction: It is used to treat COVID-19 and reduce the severity of the disease by preventing the virus from multiplying. It contains two peptidomimetic molecules, nirmatrelvir and ritonavir.
4.Posluma (flotufolastat F 18)
- Developer: Blue Earth Diagnostics
- Approval time: 2023-05-25
- Indications: Positron emission tomography imaging in patients with prostate cancer
- Delivery method: Intravenous injection
- Introduction: Positron emission tomography imaging for prostate cancer patients using PSMA targeting components for imaging.
5.Aphexda (Motixafortide, motixafortide)
- Developer: BioLineRx
- Approval time: 2023-09-08
- Indications: Collection and subsequent autologous transplantation in patients with multiple myeloma
- Delivery method: Subcutaneous injection
- Introduction: For the collection and subsequent autologous transplantation of patients with multiple myeloma, stem cells are mobilized into the peripheral blood by CXCR4 antagonists.
6.Zilbrysq(Zilucoplan)
- Developer: UCB
- Approval time: 2023-10-17
- Indications: Generalized myasthenia gravis in adults
- Delivery method: Subcutaneous injection
- Introduction: It is the first once-daily subcutaneous injection of gMG-targeted C5 complement inhibitor for the treatment of generalized myasthenia gravis in adults.
The approval of new drugs this year witnessed the joint efforts of medical research and industrial development, providing patients with more innovative treatments and writing a new chapter for building a healthier future.
No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
55 | Wainua | eplontersen | 12/21/2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
54 | Filsuvez | birch triterpenes | 12/18/2023 | To treat wounds associated with dystrophic and junctional epidermolysis bullosa |
53 | Fabhalta | iptacopan | 12/5/2023 | To treat paroxysmal nocturnal hemoglobinuria |
52 | Ogsiveo | nirogacestat | 11/27/2023 | To treat adults with progressing desmoid tumors who require systemic treatment |
51 | Truqap | capivasertib | 11/16/2023 | To treat breast cancer that meets certain disease criteria |
50 | Ryzneuta | efbemalenograstim alfa-vuxw | 11/16/2023 | To treat neutropenia |
49 | Augtyro | repotrectinib | 11/15/2023 | To treat ROS1-positive non-small cell lung cancer |
48 | Defencath | taurolidine, heparin | 11/15/2023 | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter |
47 | Fruzaqla | fruquintinib | 11/8/2023 | To treat refractory, metastatic colorectal cancer |
46 | Loqtorzi | toripalimab-tpzi | 10/27/2023 | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies |
45 | Omvoh | mirikizumab-mrkz | 10/26/2023 | To treat ulcerative colitis |
44 | Agamree | vamorolone | 10/26/2023 | To treat Duchenne muscular dystrophy |
43 | Bimzelx | bimekizumab | 10/17/2023 | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
42 | Zilbrysq | zilucoplan | 10/17/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive |
41 | Velsipity | etrasimod | 10/12/2023 | To treat moderately to severely active ulcerative colitis in adults |
40 | Rivfloza | nedosiran | 9/29/2023 | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function |
39 | Pombiliti | cipaglucosidase alfa-atga | 9/28/2023 | To treat late-onset Pompe disease |
38 | Exxua | gepirone | 9/22/2023 | To treat major depressive disorder |
37 | Ojjaara | momelotinib | 9/15/2023 | To treat intermediate or high-risk myelofibrosis in adults with anemia |
36 | Aphexda | motixafortide | 9/8/2023 | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma |
35 | Veopoz | pozelimab-bbfg | 8/18/2023 | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease |
34 | Sohonos | palovarotene | 8/16/2023 | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva |
33 | Elrexfio | elranatamab-bcmm | 8/14/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy |
32 | Talvey | talquetamab-tgvs | 8/9/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies |
31 | Izervay | avacincaptad pegol | 8/4/2023 | To treat geographic atrophy secondary to age-related macular degeneration |
30 | Zurzuvae | zuranolone | 8/4/2023 | To treat postpartum depression |
29 | Xdemvy | lotilaner | 7/25/2023 | To treat Demodex blepharitis |
28 | Vanflyta | quizartinib | 7/20/2023 | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria |
27 | Beyfortus | nirsevimab-alip | 7/17/2023 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease |
26 | Ngenla | somatrogon-ghla | 6/27/2023 | To treat growth failure due to inadequate secretion of endogenous growth hormone |
25 | Rystiggo | rozanolixizumab-noli | 6/26/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive |
24 | Litfulo | ritlecitinib | 6/23/2023 | To treat severely patchy hair loss |
23 | Columvi | glofitamab-gxbm | 6/15/2023 | To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy |
22 | Inpefa | sotagliflozin | 5/26/2023 | To treat heart failure |
21 | Posluma | flotufolastat F 18 | 5/25/2023 | To use with positron emission tomography imaging in certain patients with prostate cancer |
20 | Paxlovid | nirmatrelvir, ritonavir | 5/25/2023 | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 |
19 | Xacduro | sulbactam, durlobactam | 5/23/2023 | To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex |
18 | Epkinly | epcoritamab-bysp | 5/19/2023 | To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy |
17 | Miebo | perfluorhexyloctane | 5/18/2023 | To treat signs and symptoms of dry eye disease |
16 | Veozah | fezolinetant | 5/12/2023 | To treat moderate to severe hot flashes caused by menopause |
15 | Elfabrio | pegunigalsidase alfa-iwxj | 5/9/2023 | To treat confirmed Fabry disease |
14 | Qalsody | tofersen | 4/25/2023 | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation |
13 | Joenja | leniolisib | 3/24/2023 | To treat activated phosphoinositide 3-kinase delta syndrome |
12 | Rezzayo | rezafungin | 3/22/2023 | To treat candidemia and invasive candidiasis |
11 | Zynyz | retifanlimab-dlwr | 3/22/2023 | To treat metastatic or recurrent locally advanced Merkel cell carcinoma |
10 | Daybue | trofinetide | 3/10/2023 | To treat Rett syndrome |
9 | Zavzpret | zavegepant | 3/9/2023 | To treat migraine |
8 | Skyclarys | omaveloxolone | 2/28/2023 | To treat Friedrich’s ataxia |
7 | Filspari | sparsentan | 2/17/2023 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
6 | Lamzede | velmanase alfa-tycv | 2/16/2023 | To treat non-central nervous system manifestations of alpha-mannosidosis |
5 | Jesduvroq | daprodustat | 2/1/2023 | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months |
4 | Orserdu | elacestrant | 1/27/2023 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy |
3 | Jaypirca | pirtobrutinib | 1/27/2023 | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor |
2 | Brenzavvy | bexagliflozin | 1/20/2023 | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise |
1 | Leqembi | lecanemab-irmb | 1/6/2023 | To treat Alzheimer’s disease |
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