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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