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.
2024 | July | August | September
July 2024 – Novel FDA Drug Approvals
Donanemab-azbt
- Drug: Donanemab-azbt
- Trade name: Kisunla
- Therapeutic Area: Alzheimer’s disease MeSH D0000544
- Manufacturer: Eli Lilly
- FDA Approval Date: July 2, 2024
- Classification: Antibody
- Drug Class: Monoclonal antibodies
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ donanemab-azbt#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ donanemab-azbt#safety
- Description: Donanemab-azbt, sold under the trade name Kisunla, is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. It is administered via intravenous infusion.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf
Deuruxolitinib
- Drug: Deuruxolitinib
- Trade name: Leqselvi
- Therapeutic Area: Alopecia areata MeSH D000506
- Manufacturer: Sun Pharma
- FDA Approval Date: July 25, 2024
- Classification: Small molecule
- Drug Class: Deuterated compounds; tyrosine kinase inhibitors
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ deuruxolitinib#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ deuruxolitinib#safety
- Description: Deuruxolitinib, sold under the trade name Leqselvi, is used to treat severe alopecia areata. It is taken by mouth.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217900Orig1s000correctedlbl.pdf
August 2024 – Novel FDA Drug Approvals
Vorasidenib
- Drug: Vorasidenib
- Trade name: Voranigo
- Therapeutic Area: IDH-mutant glioma MeSH D005910
- Manufacturer: Servier Pharmaceuticals
- FDA Approval Date: August 6, 2024
- Classification: Small molecule
- Drug Class: Mutated isocitrate dehydrogenase (IDH) inhibitors
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ vorasidenib#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ vorasidenib#safety
- Description: Vorasidenib, sold under the trade name Voranigo, is used to treat Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery. It is taken by mouth.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf
Palopegteriparatide
- Drug: Palopegteriparatide
- Trade name: Yorvipath
- Therapeutic Area: Hypoparathyroidism MeSH D007011
- Manufacturer: Ascendis
- FDA Approval Date: August 9, 2024
- Classification: Small molecule
- Drug Class: Parathyroid hormone analog
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ palopegteriparatide#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ palopegteriparatide#safety
- Description: Palopegteriparatide, sold under the tradename Yorvipath, is used to treat hypoparathyroidism in adults. It is administered by subcutaneous injection.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216490s000lbl.pdf
Nemolizumab-ilto
- Drug: Nemolizumab-ilto
- Trade name: Nemluvio
- Therapeutic Area: Prurigo nodularis MeSH D011536
- Manufacturer: Galderma Laboratories, L.P
- FDA Approval Date: August 12, 2024
- Classification: Antibody
- Drug Class: Interleukin-31 receptor antagonist
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ nemolizumab-ilto#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ nemolizumab-ilto#safety
- Description: Nemolizumab-ilto, sold under the trade name Nemluvio, is used to treat prurigo nodularis. It is administered by subcutaneous injection.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761390s000lbl.pdf
Seladelpar
- Drug: Seladelpar
- Trade name: Livdelzi
- Therapeutic Area: Primary biliary cholangitis (PBC) MeSH D008105
- Manufacturer: Gilead Sciences
- FDA Approval Date: August 14, 2024
- Classification: Small molecule
- Drug Class: PPAR delta receptor agonists
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ seladelpar#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ seladelpar#safety
- Description: Seladelpar, sold under the trade name Livdelzi, is used to treat primary biliary cholangitis. It is taken by mouth.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf
Axatilimab-csfr
- Drug: Axatilimab-csfr
- Trade name: Niktimvo
- Therapeutic Area: Chronic graft-versus-host disease (cGVHD) MeSH D006086
- Manufacturer: Incyte
- FDA Approval Date: August 14, 2024
- Classification: Antibody
- Drug Class: Monoclonal antibody: Colony stimulating factor-1 receptor (CSF-1R)-blocking antibodies
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ axatilimab-csfr#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ axatilimab-csfr#safety
- Description: Axatilimab-csfr, sold under the tradename Niktimvo, is used to treat chronic graft-versus-host disease. It is administered through intravenous infusion.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761411s000lbl.pdf
Lazertinib
- Drug: Lazertinib
- Trade name: Lazcluze
- Therapeutic Area: Non-small cell lung cancer MeSH D002289
- Manufacturer: Janssen Biotech
- FDA Approval Date: August 19, 2024
- Classification: Small molecule
- Drug Class: Tyrosine kinase inhibitors: epidermal growth factor receptor (EGFR) inhibitors
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ lazertinib#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ lazertinib#safety
- Description: Lazertinib, sold under the trade name Lazcluze, is used for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer. It is taken by mouth.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbl.pdf
September 2024 – Novel FDA Drug Approvals
Lebrikizumab-lbkz
- Drug: Lebrikizumab-lbkz
- Trade name: Ebglyss
- Therapeutic Area: Moderate-to-severe atopic dermatitis MeSH D003876
- Manufacturer: Eli Lilly
- FDA Approval Date: September 13, 2024
- Classification: Antibody
- Drug Class: Monoclonal antibodies: Interleukin-13 antagonist
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ lebrikizumab-lbkz#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ lebrikizumab-lbkz#safety
- Description: Lebrikizumab-lbkz, sold under the trade name Ebglyss, is used to treat moderate-to-severe atopic dermatitis. It is administered by injection.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761306Orig1s000correctedlbl.pdf
Arimoclomol
- Drug: Arimoclomol
- Trade name: Miplyffa
- Therapeutic Area: Niemann-Pick disease type C MeSH D052556
- Manufacturer: Zevra Therapeutics
- FDA Approval Date: September 20, 2024
- Classification: Small molecule
- Drug Class: heat-shock protein inducers, bimoclomal type
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ arimoclomol#clinical
- Adverse Events: https://www.app.pharmakb.com/drug-report/ arimoclomol#safety
- Description: Arimoclomol, sold under the trade name Miplyffa, is used in combination with the enzyme inhibitor miglustat, to treat neurological symptoms associated with Niemann-Pick disease type C in adults and children 2 years of age and older. It is taken by mouth.
- FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-niemann-pick-disease-type-c
Levacetylleucine
- Drug: Levacetylleucine
- Trade name: Aqneursa
- Therapeutic Area: Niemann-Pick disease type MeSH D052556
- Manufacturer: IntraBio Inc.
- FDA Approval Date: September 24, 2024
- Classification: Small molecule
- Drug Class: Antivertigo preparation
- Clinical Trials: https://www.app.pharmakb.com/drug-report/ levacetylleucine#clinical
- Adverse Events: e.g. https://www.app.pharmakb.com/drug-report/ levacetylleucine#safety
- Description: Levacetylleucine, sold under the trade name Aqneursa, is used for treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kilograms. It is taken by mouth.
- FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-niemann-pick-disease-type-c
Xanomeline and trospium chloride
- Drug: Xanomeline and trospium chloride
- Trade name: Cobenfy
- Therapeutic Area: Schizophrenia MeSH D012559
- Manufacturer: Bristol Myers Squibb
- FDA Approval Date: September 26, 2024
- Classification: Small molecule
- Drug Class: Quaternary ammonium derivatives
- Clinical Trials: https://www.pharmakb.com/drug-report/xanomeline-and-trospium-chloride#clinical
- Adverse Events: https://www.pharmakb.com/drug-report/xanomeline-and-trospium-chloride#safety
- Description: Xanomeline and trospium chloride, sold under the trade name Cobenfy, is used to treat schizophrenia, targeting cholinergic receptors as opposed to dopamine receptors. It is taken by mouth.
- FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia
Flurpiridaz F 18
- Drug: Flurpiridaz F 18
- Trade name: Flyrcado
- Therapeutic Area: Radioactive diagnostics for myocardial ischemia and infarction MeSH D017202, D009203
- Manufacturer: GE Healthcare
- FDA Approval Date: September 27, 2024
- Classification: Small molecule
- Drug Class: Diagnostic radiopharmaceuticals
- Clinical Trials: https://www.pharmakb.com/drug-report/flurpiridaz2018f#clinical
- Adverse Events: https://www.pharmakb.com/drug-report/flurpiridaz2018f#safety
- Description: Flurpiridaz F 18, sold under the trade name Flyrcado, is a radioactive diagnostic drug to evaluate for myocardial ischemia and infarction. It is administered through intravenous injection.
- FDA News Release: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215168s000lbl.pdf
