Novel FDA Drug Approvals - 3rd Quarter of 2024 - PharmaKB Report

Written by Dr. Yigit Kucuk | Oct 31, 2024 4:14:57 PM

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

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