| Amtagvi® | | AMTAGVI (lifileucel suspension for intravenous infusion) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma. It is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. | Licensee: | Iovance Biotherapeutics, Inc | FDA Approval: | February 16, 2024 | First Commercial U.S. Sale: | 2024 | Agency: | NIH | U.S. Patents: | 8,034,334; 8,383,099; 8,287,857; 8,556,882; 9,074,185; 9,844,569; 10,716,809; 11,077,182; 11,331,385; 11,338,032; 11,376,318; 11,401,503; 11,679,128; 11,918,640 | | | | Arexvy® | | Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Based on a recombinant subunit prefusion RSV F glycoprotein antigen it is the first RSV vaccine for older adults to be approved anywhere in the world. | Licensee: | GlaxoSmithKline | FDA Approval: | May 3, 2023 | First Commercial U.S. Sale: | 2023 | Agency: | NIH | | U.S. Patents: | 9,738,689; 10,858,400; 11,130,785; 11,174,292 | | | | Spikevax® | | Spikevax (COVID-19 vaccine, mRNA) is a messenger RNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. | Licensee: | ModernaTX, Inc. | FDA Approval: | January 31, 2022 | First Commercial U.S. Sale: | 2020 (EUA) | Agency: | NIH | U.S. Patents: | 10,960,070 |
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| Comirnaty® |
| Comirnaty (COVID-19 vaccine, mRNA) is a messenger RNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. |
| Licensee: | BioNTech/Pfizer |
| FDA Approval: | August 23, 2021 |
| First Commercial U.S. Sale: | 2020 (EUA) |
| Agency: | NIH |
| U.S. Patents: | 10,960,070 |
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| Abecma® |
| Abecma (idecabtagene viceocel) is a chimeric antigen receptor (CAR) T-cell therapy treatment for multiple myeloma. It is used for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies. |
| Licensee: | Bluebird Bio |
| FDA Approval: | March 26, 2021 |
| First Commercial U.S. Sale: | 2021 |
| Agency: | NIH |
| U.S. Patents: | 9,765,342; 10,767,184; 10,815,487; 10,738,312; 10,738,313, 10,844,387; 10,829,767; 10,900,042; 10,876,123; 10,815,488; 10,829,768; 10,837,019; 10,829,769 |
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| Ebanga® |
| Ebanga (ansuvimab-zykl) is a human monoclonal antibody for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. |
| Licensee: | Ridgeback Biotherapeutics |
| FDA Approval: | December 21, 2020 |
| First Commercial U.S. Sale: | 2021 |
| Agency: | NIH |
| U.S. Patents: | 10,160,795; 10,273,288 |
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| Zokinvy® |
| Zokinsky (lonafarnib) is a farnesyltransferase inhibitor that helps prevent the buildup of defective progerin or progerin-like protein of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). Hutchinson-Gilford and progeroid laminopathies are two distinct fatal diseases marked by premature aging. |
| Licensee: | Progeria Research Foundation/Elger Biopharmaceuticals |
| FDA Approval: | November 20, 2020 |
| First Commercial U.S. Sale: | 2021 |
| Agency: | NIH |
| U.S. Patents: | 7,838,531; 8,257,915; 8,691,501; 8,828,356 |
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Tecartus® | | Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy for the treatment of mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (ALL). | Licensee: | Kite Pharma | | FDA Approval: | July 24, 2020 | | First Commercial U.S. Sale: | 2020 | | Agency: | NIH | | U.S. Patents: | 9,855,298; 10,322,146 |
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Spravato® | Spravato (esketamine) is a nasal spray used in conjunction with an oral antidepressant for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). | | Licensee: | Janssen Therapeutics | | FDA Approval: | March 6, 2019 | | First Commercial U.S. Sale: | 2019 | | Agency: | NIH | | U.S. Patents: | 8,785,500; 9,539,220; 9,592,207 |
Lumoxiti™ | Lumoxiti is a CD22-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). | Licensee: | AstraZeneca | FDA Approval: | September 13, 2018 | First Commercial U.S. Sale: | 2019 | Agency: | NIH | U.S. Patents: | 4,892,827; 5,747,654; 5,980,895; 6,074,644; 6,147,203; 6,558,672; 7,355,012; 7,541,034; 7,777,019; 7,982,011; 8,809,502; 9,592,304 | | | | Luxturna® | | Luxturna (voretigene neparvovec-rzyl) is a new gene therapy to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. | Licensee: | Spark Therapeutics | FDA Approval: | December 18, 2017 | First Commercial U.S. Sale: | 2018 | Agency: | NIH | U.S. Patents: | 7,419,817 | | |
Yescarta® | A chimeric antigen receptor (CAR) genetically modified autologous T cell immunotherapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. | Licensee: | Kite Pharma | FDA Approval: | October 18, 2017 | First Commercial U.S. Sale: | 2018 | Agency: | NIH | U.S. Patents: | 9,855,298; 10,322,146 | | |
Ella® | A progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. | Licensee: | Laboratoire HRA Pharma | FDA Approval: | March 10, 2015 | First Commercial U.S. Sale: | 2016 | Agency: | NIH | U.S. Patents: | 9,283,233; 9,616,073; 10,159,681 | | |
Myalept® | Myaylept (metreleptin) is an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Lipodystrophy is a rare disorder characterized by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and is associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease. | | Licensee: | Aegerion Pharmaceuticals, Inc. | | FDA Approval: | February 25, 2014 | | First Commercial U.S. Sale: | 2014 | | Agency: | NIH | | U.S. Patent: | 7,183,254; 8,318,666 | | |
Velcade® | A treatment for multiple myeloma that works by specifically inhibiting an enzyme complex known as the proteosome. Under an accelerated approval program, the FDA has allowed the use of Velcade® in patients who have failed two prior therapies. The selectivity and manageable side-effect profile of this boronic dipeptide compound makes it an exciting new cancer drug. NIH researchers made a critical contribution by developing stable, pharmaceutically acceptable compositions of these important compounds. Indeed, as the first proteosome inhibitor to be approved by the FDA, Velcade® opens the door for a new class of useful drugs. | Licensee: | Millennium Pharmaceuticals | FDA Approval: | May 13, 2003 | First Commercial U.S. Sale: | 2003 | Agency: | NIH | U.S. Patents: | 6,699,835; 6,713,446; 6,958,319;
7,109,323 | | | | Archive of Products Previously Developed Using HHS Technologies |
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