Novel FDA Drug Approvals - 3rd Quarter of 2023 - PharmaKB Report

The Pharmaceutical KnowledgeBase (PharmaKB.com) provides research and financial intelligence about companies and their approved drugs as well as drug candidates in clinical trials. In this quarterly PharmaKB report, we provide an update about novel drugs approved by the US FDA in of this year.  By referencing new drugs as “novel” the FDA is confirming that the medicine being approved contains ingredients and/or a mechanism of action that the FDA hasn’t previously approved. 

2023 | July | August | September

July 2023 – Novel FDA Drug Approvals

Nirsevimab-alip

• Drug: Nirsevimab
• Trade name: Beyfortus
• Therapeutic Areas: Respiratory syncytial virus infections (RSV) MeSH D018357
• Manufacturer: AstraZeneca
• FDA Approval Date: July 17, 2023
• Classification: Antibody
• Drug Class: Monoclonal antibodies
• Clinical Trials: https://app.pharmakb.com/drugs/Nirsevimab#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Nirsevimab#safety
• Description: Nirsevimab-alip, sold under the trade name Beyfortus, is used for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers

Quizartinib

• Drug: Quizartinib  
• Trade name: Vanflyta
• Therapeutic Areas: Neoplasms MeSH D009369
• Manufacturer: Daiichi Pharmaceutical
• FDA Approval Date: July 20, 2023
• Classification: Small molecule
• Drug Class: tyrosine kinase inhibitors
• Clinical Trials: https://app.pharmakb.com/drugs/Quizartinib#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Quizartinib#safety
• Description: Quizartinib, sold under the trade name Vanflyta, is used as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria.
• FDA News Release: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia

Lotilaner

• Drug: Lotilaner
• Trade name: Xdemvy
• Therapeutic Areas: Demodex blepharitis
• Manufacturer: Tarsus Pharmaceuticals
• FDA Approval Date: July 25, 2023
• Classification: Protein
• Drug Class: Gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor
• Clinical Trials: https://app.pharmakb.com/drugs/Lotilaner#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Lotilaner#safety
• Description: Lotilaner, sold under the trade name Xdemvy, is an ectoparasiticide indicated for the treatment of Demodex blepharitis.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217603s000lbl.pdf

August 2023 – Novel FDA Drug Approvals

Zuranolone

• Drug: Zuranolone
• Trade name: Zurzuvae
• Therapeutic Areas: Postpartum depression MeSH D003865
• Manufacturer: Sage Therapeutics
• FDA Approval Date: August 4, 2023
• Classification: Small molecule
• Drug Class: Steroids (not prednisolone derivatives)
• Clinical Trials: https://app.pharmakb.com/drugs/Zuranolone#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Zuranolone#safety
• Description: Zuranolone, sold under the trade name Zurzuvae, is used to treat postpartum depression.
• FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression

Avacincaptad pegol

• Drug: Avacincaptad
• Trade name: Izervay
• Therapeutic Areas: Geographic atrophy
• Manufacturer: Iveric Bio
• FDA Approval Date: August 4, 2023
• Classification: Small molecule
• Drug Class: anti-angiogenic ophthalmic agents
• Clinical Trials: https://app.pharmakb.com/drugs/Avacincaptad#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Avacincaptad#safety
• Description: Avacincaptad, sold under the trade name Izervay, is used to treat geographic atrophy secondary to age-related macular degeneration.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217225s000lbl.pdf

Talquetamab-tgvs

• Drug: Talquetamab
• Trade name: Talvey
• Therapeutic Areas: Multiple myeloma MeSH D009101
• Manufacturer: Janssen Pharmaceutical Companies
• FDA Approval Date: August 9, 2023
• Classification: Antibody
• Drug Class: Monoclonal
• Clinical Trials: https://app.pharmakb.com/drugs/Talquetamab#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Talquetamab#safety
• Description: Talquetamab, sold under the trade name Talvey, is used to treat multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma. It is known to target G-protein coupled receptor family C group 5 member D.
• FDA News Release: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-talvey-talquetamab-tgvs-relapsed-or-refractory-multiple

Elranatamab-bcmm

• Drug: Elranatamab
• Trade name: Elrexfio
• Therapeutic Areas: Multiple myeloma MeSH D009101
• Manufacturer: Pfizer
• FDA Approval Date: August 14, 2023
• Classification: Antibody
• Drug Class: Monoclonal antibody
• Clinical Trials: https://app.pharmakb.com/drugs/Elranatamab#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Elranatamab#safety
• Description: Elranatamab, sold under the brand name Elrexfio, is used to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. Elranatamab is administered subcutaneously.
• FDA News Release: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma

Palovarotene

• Drug: Palovarotene
• Trade name: Sohonos
• Therapeutic Areas: Myositis ossificans MeSH D009221
• Manufacturer: Ipsen
• FDA Approval Date: August 16, 2023
• Classification: Small molecule
• Drug Class: Arotinoid derivatives
• Clinical Trials: https://app.pharmakb.com/drugs/Palovarotene#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Palovarotene#safety
• Description: Palovarotene, sold under the trade name Sohonos, is used 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 progressive.
• FDA News Release: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-fibrodysplasia-ossificans-progressiva

Pozelimab-bbfg

• Drug: Pozelimab
• Trade name: Veopoz
• Therapeutic Areas: Digestive system diseases MeSH D004066
• Manufacturer: Regeneron
• FDA Approval Date: August 18, 2023
• Classification: Antibody
• Drug Class: Monoclonal antibodies
• Clinical Trials: https://app.pharmakb.com/drugs/Pozelimab#clinical
• Adverse Events: https://app.pharmakb.com/drugs/Pozelimab#safety
• Description: Pozelimab, sold under the trade name Veopoz, is used to treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. It is known to target complement C5. An initial dose of Veopoz is administered intravenously, followed by weekly injections given subcutaneously by a health care provider.
• FDA News Release: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-cd55-deficient-protein-losing-enteropathy-chaple-disease
  
  

September 2023 – Novel FDA Drug Approvals

Motixafortide

• Drug: Motixafortide
• Trade name: Aphexda    
• Therapeutic Area: Hematopoietic stem cell mobilizer
• Manufacturer: BioLineRx
• FDA Approval Date: September 8, 2023 (via FDA Accelerated Approval Program)
• Classification: Small Protein
• Drug Class: Chemokine receptor inhibitor
• Clinical Trials: https://www.app.pharmakb.com/drug-report/motixafortide#clinical
• Adverse Events:  https://www.app.pharmakb.com/drug-report/motixafortide#safety
• Description: Motixafortide, sold under the trade name Aphexda, is used with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma, administered subcutaneously.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217159s000lbl.pdf

Momelotinib

• Drug: Momelotinib
• Trade name: Ojjaara    
• Therapeutic Area: Myelofibrosis MeSH D055728
• Manufacturer: GlaxoSmithKline
• FDA Approval Date: September 15, 2023 (via FDA Accelerated Approval Program)
• Classification: Small molecule
• Drug Class: Tyrosine kinase inhibitors
• Clinical Trials: https://www.app.pharmakb.com/drug-report/momelotinib#clinical
• Adverse Events:  https://www.app.pharmakb.com/drug-report/momelotinib#safety
• Description: Momelotinib, sold under the trade name Ojjaara, is used to treat intermediate or high-risk myelofibrosis in adults with anemia, taken orally.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216873s000lbl.pdf

Gepirone

• Drug: Gepirone
• Trade name: Exxua    
• Therapeutic Area: Major depressive disorder MeSH D003865
• Manufacturer: Fabre-Kramer Pharmaceuticals
• FDA Approval Date: September 22, 2023 (via FDA Accelerated Approval Program)
• Classification: Small molecule
• Drug Class: Selective partial agonist
• Clinical Trials: https://www.app.pharmakb.com/drug-report/gepirone#clinical
• Adverse Events: https://www.app.pharmakb.com/drug-report/gepirone#safety
• Description: Gepirone, sold under the trade name of Exxua, is used to treat major depressive disorder, administered through extended-release tablets.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021164Orig1s000ltr.pdf

Cipaglucosidase alfa-atga

• Drug: Cipaglucosidase alfa-atga
• Trade name: Pombiliti    
• Therapeutic Area: Pompe disease MeSH D006009
• Manufacturer: Amicus Therapeutics
• FDA Approval Date: September 28, 2023 (via FDA Accelerated Approval Program)
• Classification: Enzyme
• Drug Class: Enzymes
• Clinical Trials: https://www.app.pharmakb.com/drug-report/cipaglucosidase20alfa#clinical
• Adverse Events:  https://www.app.pharmakb.com/drug-report/cipaglucosidase20alfa#safety
• Description: Cipaglucosidase alfa-atga, sold under the trade name Pombiliti, is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). It is administered as an intravenous infusion.
• FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761204s000lbl.pdf

Nedosiran

• Drug: Nedosiran
• Trade name: Rivfloza    
• Therapeutic Area: Primary hyperoxaluria MeSH D006960
• Manufacturer: Pyramid Laboratories
• FDA Approval Date: September 29, 2023 (via FDA Accelerated Approval Program)
• Classification: Oligonucleotide
• Drug Class: Double-stranded siRNA
• Clinical Trials: https://www.app.pharmakb.com/drug-report/nedosiran#clinical
• Adverse Events:  https://www.app.pharmakb.com/drug-report/nedosiran#safety
• Description: Nedosiran, sold under the trade name Rivfloza, is used to lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function, administered subcutaneously.

FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf