Directory of Novel FDA Approvals, 2024

Directory of Novel FDA Approvals, 2024

FDA News, Infectious Diseases, Mental Health, Oncology, Rare Diseases, Pain Management, Pharmacy, Hemophilia, Cardiovascular Disease

December 2024, Vol 1, No 2

Orlynvah (sulopenem etzadroxil, probenecid; Iterum Therapeutics)
Class/route: Novel oral penem antibiotic
Indication: To treat uncomplicated urinary tract infections
Approval date: October 25, 2024¹

Vyloy (zolbetuximab-clzb; Astellas)
Class/route: Use in combination with fluoropyrimidine- and platinum-containing chemotherapy
Indication: To treat gastric or gastroesophageal junction cancer
Approval date: October 18, 2024²

Hympavzi (marstacimab-hncq; Pfizer)
Class/route: Prefilled autoinjector pen
Indication: To prevent or reduce bleeding episodes related to hemophilia A or B
Approval date: October 11, 2024³

Itovebi (inavolisib; Genentech)
Class/route: Tablet
Indication: To treat locally advanced or metastatic cancer
Approval date: October 10, 2024⁴

Flyrcado (flurpiridaz F 18; GE Healthcare)
Class/route: Diagnostic agent
Indication: To diagnose and evaluate for myocardial ischemia and infarction
Approval date: September 27, 2024⁵

Cobenfy (xanomeline and trospium chloride; Bristol Myers Squibb)
Class/route: Musarinic agonist
Indication: To treat schizophrenia
Approval date: September 26, 2024⁶

Aqneursa (levacetylleucine; IntraBio Inc)
Class/route: Granules
Indication: To treat Niemann-Pick disease type C
Approval date: September 24, 2024⁷

Miplyffa (arimoclomol, Zefra Therapeutics)
Class/route: Capsule
Indication: To treat Niemann-Pick disease type C
Approval date: September 20, 2024⁸

Ebglyss (lebrikizumab-lbkz; Eli Lilly)
Class/route: Interleukin-13 antagonist/subcutaneous injection
Indication: To treat moderate-to-severe atopic dermatitis
Approval date: September 13, 2024⁹

Lazcluze (lazertinib; Janssen Biotech, Inc)
Class/route: EGFR inhibitor/oral
Indication: To treat non–small cell lung cancer
Approval date: August 19, 2024¹⁰

Niktimvo (axatilimab-csfr; Incyte Corporation and Syndax Pharmaceuticals)
Class/route: CSF-1R-blocking antibody/intravenous infusion
Indication: To treat chronic graft-versus-host disease
Approval date: August 14, 2024¹¹

Livdelzi (seladelpar; Gilead)
Class/route: PPAR-delta agonist/oral
Indication: To treat primary biliary cholangitis
Approval date: August 14, 2024¹²

Nemluvio (nemolizumab-ilto; Galderma Laboratories)
Class/route: Interleukin-31 receptor antagonist/subcutaneous injection
Indication: To treat prurigo nodularis
Approval date: August 12, 2024¹³

Yorvipath (palopegteriparatide; Ascendis Pharma)
Class/route: Parathyroid hormone analog/subcutaneous injection
Indication: To treat hypoparathyroidism
Approval date: August 9, 2024¹⁴

Voranigo (vorasidenib; Servier)
Class/route: Oral
Indication: Grade 2 astrocytoma or oligodendroglioma
Approval date: August 6, 2024¹⁵

Leqselvi (deuruxolitinib; Sun)
Class/route: JAK inhibitor/oral
Indication: To treat severe alopecia areata
Approval date: July 25, 2024¹⁶

Kisunla (donanemab-azbt; Eli Lilly)
Class/route: Amyloid beta-directed antibody/intravenous
Indication: To treat Alzheimer’s disease
Approval date: July 2, 2024¹⁷

Ohtuvayre (ensifentrine; Verona Pharma)
Class/route: PDE3/4/inhalation
Indication: To treat chronic obstructive pulmonary disease
Approval date: June 26, 2024¹⁸

Piasky (crovalimab-akkz; Genentech)
Class/route: Complement C5 inhibitor/intravenous
Indication: To treat paroxysmal nocturnal hemoglobinuria
Approval date: June 20, 2024¹⁹

Sofdra (sofpironium; Botanix Pharmaceuticals Limited)
Class/route: Anticholinergic/topical
Indication: To treat primary axillary hyperhidrosis
Approval date: June 18, 2024²⁰

Iqirvo (elafibranor; Ipsen)
Class/route: PFAR/oral
Indication: To treat primary biliary cholangitis in combination with ursodeoxycholic acid
Approval date: June 10, 2024²¹

Rytelo (imetelstat; Geron Corp)
Class/route: Telomerase inhibitor/intravenous
Indication: To treat low- to intermediate-1 risk myelodysplastic syndromes
Approval date: June 6, 2024²²

Imdelltra (tarlatamab-dlle; Amgen)
Class/route: DLL3-targeting BiTE therapy intravenous
Indication: To treat extensive-stage small cell lung cancer
Approval date: May 16, 2024²³

Xolremdi (mavorixafor; X4)
Class/route: CXCR4/oral
Indication: To treat WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis)
Approval date: April 26, 2024²⁴

Ojemda (tovorafenib; Day One Biopharmaceuticals)
Class/route: Type 2 RAF inhibitor/oral
Indication: To treat relapsed or refractory pediatric low-grade glioma
Approval date: April 23, 2024²⁵

Anktiva (nogapendekin alfa inbakicept-pmln; Altor Bioscience)
Class/route: IL-15 receptor agonist/intravenous
Indication: Bladder cancer
Approval date: April 22, 2024²⁶

Lumisight (pegulicianine; Lumicell)
Class/route: Imaging tool
Indication: To use as an optical imaging agent for detecting cancerous tissue
Approval date: April 17, 2024²⁷

Zevtera (ceftobiprole medocaril sodium; Basilea Pharmaceutica International)
Class/route: Injection
Indication: To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia
Approval date: April 3, 2024²⁸

Voydeya (danicopan; Alexion)
Class/route: Complement factor D inhibitor/oral
Indication: To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria
Approval date: March 29, 2024²⁹

Vafseo (vadadustat; Akelba Therapeutics)
Class/route: HIF-PH inhibitor/oral
Indication: To treat anemia due to chronic kidney disease
Approval date: March 27, 2024³⁰

Winrevair (sotatercept-csrk; Merck)
Class/route: Activin signaling inhibitor/subcutaneous injection
Indication: To treat pulmonary arterial hypertension
Approval date: March 26, 2024³¹

Duvyzat (givinostat; ITF Therapeutics)
Class/route: HDAC inhibitor/oral
Indication: To treat Duchenne muscular dystrophy in individuals aged ≥6 years
Approval date: March 21, 2024³²

Tryvio (aprocitentan; Idorsia)
Class/route: Endothelin receptor antagonist/oral
Indication: To treat hypertension
Approval date: March 19, 2024³³

Rezdiffra (resmetirom; Madrigal Pharmaceuticals)
Class/route: Thyroid hormone receptor-beta agonist/oral
Indication: To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring
Approval date: March 14, 2024³⁴

Tevimbra (tislelizumab-jsgr; BeiGene)
Class/route: Checkpoint inhibitor/intravenous
Indication: To treat unresectable or metastatic esophageal squamous cell carcinoma
Approval date: March 13, 2024³⁵

Letybo (letibotulinumtoxinA-wlbg; Hugel Inc)
Class/route: Intramuscular
Indication: To temporarily improve the appearance of moderate to severe glabellar lines (brow furrows) in adults
Approval date: February 29, 2024³⁶

Exblifep (cefepime; enmetazobactam, Allecra)
Class/route: Intravenous
Indication: To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms
Approval date: February 2, 2024³⁷

Zelsuvmi (berdazimer; Ligand Pharmaceuticals)
Class/route: Topical
Indication: Treatment of molluscum contagiosum
Approval date: January 5, 2024³⁸

References

Iterum Therapeutics. Iterum Therapeutics receives US FDA approval of Orlynvah™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections [press release]. Published October 25, 2024. Accessed November 4, 2024. https://www.iterumtx.com/news/press-releases/detail/136/iterum-therapeutics-receives-u-s-fda-approval-of#xd_co_f=ZjhjNDUwM2MtZDE3Mi00MTMxLTkwZWItOGRjYWFkZjI5ZjA0~
Astellas. Astellas’ Vyloy™ (zolbetuximab-clzb) approved by US FDA for treatment of advanced gastric and GEJ cancer [press release]. Published October 18, 2024. Accessed November 4, 2024. https://www.prnewswire.com/news-releases/astellas-vyloy-zolbetuximab-clzb-approved-by-us-fda-for-treatment-of-advanced-gastric-and-gej-cancer-302280716.html
Pfizer. US FDA approves Pfizer’s Hympavzi™ (marstacimab-hncq) for the treatment of adults and adolescents with hemophilia A or B without inhibitors [press release]. Published October 11, 2024. Accessed November 4, 2024. https://www.businesswire.com/news/home/20241009505480/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-HYMPAVZI%E2%84%A2-marstacimab-hncq-for-the-Treatment-of-Adults-and-Adolescents-with-Hemophilia-A-or-B-Without-Inhibitors
Genentech. FDA approves Genentech’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [press release]. Published October 10, 2024. Accessed November 4, 2024. https://www.businesswire.com/news/home/20241008295168/en/FDA-Approves-Genentech%E2%80%99s-Itovebi-a-Targeted-Treatment-for-Advanced-Hormone-Receptor-Positive-HER2-Negative-Breast-Cancer-With-a-PIK3CA-Mutation
FDA. FDA approves imaging drug for evaluation of myocardial ischemia and infarction [press release]. Published September 27, 2024. Accessed November 4, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-evaluation-myocardial-ischemia-and-infarction
Bristol Myers Squibb. US Food and Drug Administration approves Bristol Myers Squibb’s Cobenfy™ (xanomeline and trospium chloride), a first-in-class muscarinic agonist for the treatment of schizophrenia in adults [press release]. September 27, 2024. Accessed November 4, 2024. https://www.businesswire.com/news/home/20240925382351/en/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibb%E2%80%99s-COBENFY%E2%84%A2-xanomeline-and-trospium-chloride-a-First-In-Class-Muscarinic-Agonist-for-the-Treatment-of-Schizophrenia-in-Adults
IntraBio Inc. IntraBio announces US FDA approval of Aqneursa for the treatment of Niemann-Pick disease type C [press release]. Published September 25, 2024. Accessed November 4, 2024. https://www.businesswire.com/news/home/20240925347296/en/IntraBio-Announces-U.S.-FDA-Approval-of-AQNEURSA-for-the-Treatment-of-Niemann-Pick-Disease-Type-C
FDA. FDA approves first treatment for Niemann-Pick disease, type C [press release]. September 20, 2024. Accessed November 4, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-niemann-pick-disease-type-c
Lilly. FDA approves Lilly’s EBGLYSS™ (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis [press release]. September 13, 2024. Accessed September 20, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with
FDA. FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer [press release]. August 19, 2024. Accessed September 20, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer
FDA. FDA approves of axatilimab-csfr for chronic graft-versus-host disease [press release]. August 14, 2024. Accessed September 20, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axatilimab-csfr-chronic-graft-versus-host-disease
Gilead. Gilead’s Livdelzi (Seladelpar) granted accelerated approval for primary biliary cholangitis by U.S. FDA. August 14, 2024. Accessed August 14, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-seladelpar-granted-accelerated-approval-for-primary-biliary-cholngitis-by-us-fda
Galderma. Galderma receives US FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Published August 13, 2024. Accessed September 20, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
Ascendis Pharma. FDA approves Yorvipath (palopegteriparatide) as the first and only treatment for hypoparathyroidism in adults [press release]. August 12, 2024. Accessed September 20, 2024. https://investors.ascendispharma.com/news-releases/news-release-details/
FDA. FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation [press release]. August 6, 2024. Accessed October 14, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-susceptible-idh1-or-idh2-mutation
Sun Pharmaceutical Industries. U.S. FDA approves LEQSELVI™ (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata [press release]. July 26, 2024. Accessed July 26, 2024. https://www.prnewswire.com/news-releases/us-fda--approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html?tc=eml_cleartime
Eli Lilly and Company. FDA approval of Kisunla (donanemab-azbt) [press release]. July 2, 2024. Accessed September 20, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early?utm_source=li&utm_medium=organic&utm_campaign=alz_donli&utm_id=alz
Verona Pharma. FDA approval of Ohtuvayre (ensifentrine) [press release]. June 26, 2024. Accessed September 20, 2024. https://www.veronapharma.com/news/verona-pharma-announces-us-fda-approval-of-ohtuvayre-ensifentrine/
Genentech, Inc. FDA approval of Piasky (crovalimab-akkz) [package insert]. June 20, 2024. Accessed September 20, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761388s000lbl.pdf
Botanix Pharmaceuticals Limited. FDA approval of Sofdra (sofpironium) – the first new drug for primary axillary hyperhidrosis [press release]. June 20, 2024. Accessed September 20, 2024. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299
Ipsen. Ipsen’s Iqirvo receives FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis [press release]. June 10, 2024. Accessed September 20, 2024 https://www.ipsen.com/press-releases/ipsens-iqirvo-receives-u-s-fda-accelerated-approval-as-a-first-in-class-ppar-treatment-for-primary-biliary-cholangitis/
Geron Corporation. Geron announces FDA approval of RYTELO™ (imetelstat), a first-in-class telomerase inhibitor, for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia [press release]. June 6, 2024. Accessed September 20, 2024. https://ir.geron.com/investors/press-releases/press-release-details/2024/Geron-Announces-FDA-Approval-of-RYTELO-imetelstat-a-First-in-Class-Telomerase-Inhibitor-for-the-Treatment-of-Adult-Patients-with-Lower-Risk-MDS-with-Transfusion-Dependent-Anemia/default.aspx
Amgen Inc. FDA approves ImDelltra, the first and only t-cell engager therapy for the treatment of extensive-stage small cell lung cancer [press release]. May 16, 2024. Accessed September 20, 2024. https://www.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treatment-of-extensivestage-small-cell-lung-cancer
X4 Pharmaceuticals. X4 Pharmaceuticals announces FDA approval of XOLREMDI™ (mavorixafor) capsules, first drug indicated in patients with WHIM syndrome [press release]. April 26, 2024. Accessed September 20, 2024. https://investors.x4pharma.com/news-releases/news-release-details/x4-pharmaceuticals-announces-fda-approval-xolremditm-mavorixafor
Day One Biopharmaceuticals, Inc. Day One’s Ojemda (tovorafenib) receives US FDA accelerated approval for relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG), the most common form of childhood brain tumor [press release]. April 23, 2024. Accessed September 20, 2024. https://ir.dayonebio.com/news-releases/news-release-details/day-ones-ojemdatm-tovorafenib-receives-us-fda-accelerated
Altor BioScience, LLC (a subsidiary of ImmunityBio, Inc.). ImmunityBio announces FDA approval of ANKTIVA^®, first-in-class IL-15 receptor agonist for BCG-unresponsive non-muscle invasive bladder cancer [press release]. April 22, 2024. Accessed September 20, 2024. https://immunitybio.com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/
FDA. FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy. April 17, 2024. Accessed October 14, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-assist-detection-cancerous-tissue-following-lumpectomy
FDA. FDA approves new antibiotic for three different uses. April 3, 2024. Accessed October 14, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses
AstraZeneca. Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH [press release]. April 1, 2024. Accessed September 20, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/voydeya-approved-in-us.html
Akebia Therapeutics, Inc. Akebia receives FDA approval of Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease in adult patients on dialysis [press release]. March 27, 2024. Accessed September 20, 2024. https://prnmedia.prnewswire.com/news-releases/akebia-receives-fda-approval-of-vafseo-vadadustat-tablets-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-in-adult-patients-on-dialysis-302101854.html
Merck & Co., Inc. FDA approves Merck’s Winrevair (sotatercept-csrk), a first-in-class treatment for adults with pulmonary arterial hypertension (PAH, WHO*Group 1) [press release]. March 26, 2024. Accessed September 20, 2024. https://www.merck.com/news/fda-approves-mercks-winrevair-sotatercept-csrk-a-first-in-class-treatment-for-adults-with-pulmonary-arterial-hypertension-pah-who-group-1/
ITF Therapeutics LLC (a subsidiary of Italfarmaco). FDA approves nonsteroidal treatment for Duchenne muscular dystrophy [press release]. FDA. March 21, 2024. Accessed September 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nonsteroidal-treatment-duchenne-muscular-dystrophy
Idorsia Pharmaceuticals. US FDA approves Idorsia’s once-daily TRYVIO (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives [press release]. March 20, 2024. Accessed September 20, 2024. https://ml-eu.globenewswire.com/Resource/Download/17ffadbf-f3bf-4f88-8aa6-6046dc84b499
Madrigal Pharmaceuticals. Rezdiffra (resmetirom) [package insert]. March 14, 2024. Accessed September 20, 2024. https://www.madrigalpharma.com/wp-content/uploads/2024/03/Patient-Prescribing-Information.pdf
BeiGene, Ltd. BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy [press release]. March 14, 2024. Accessed September 14, 2024. https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/
Hugel, Inc. March 4, 2024. Accessed November 5, 2024. Hugel receives FDA approval in the United States of Letybo (letibotulinumtoxinA-wlbg) for injection for the treatment of glabellar lines. https://www.prnewswire.com/news-releases/hugel-receives-fda-approval-in-the-united-states-of-letybo-letibotulinumtoxina-wlbg-for-injection-for-the-treatment-of-glabellar-lines-302078434.html
Allecra Therapeutics. Exblifep. [package insert.] Accessed February 27, 2024. Accessed November 5, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf.
Ligand Pharmaceuticals. Zelsuvmi (berdazimer) [package insert]. January 5, 2024. Accessed September 20, 2024. https://zelsuvmi.com/wp-content/uploads/2024/01/ZELSUVMI-Berdazimer-Topical-Gel-10.3.-Prescribing-Information-and-Instructions-for-Use.pdf.

EDITOR’S NOTE: This listing and references are current as of November 4, 2024. They were generated partially using artificial intelligence assistance.

Directory of Novel FDA Approvals, 2024

References

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