2022 FDA Drug Approval List, 2022 Biological Approvals and Approved Cellular and Gene Therapy Products
Reporter: Aviva Lev-Ari, PhD, RN
SOURCE
Tal Bahar’s post on LinkedIn on 1/17/2023
Novel Drug Approvals for 2022
FDA’s Center for Drug Evaluation and Research (CDER)
New Molecular Entities (“NMEs”)
- Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
INNOVATION PREDICTABILITY ACCESS FDA’s Center for Drug Evaluation and Research
January 2023
Table of Contents
- Director’s Message
- Executive Summary
- CDER’s Novel Drug Approvals of 2022
- Innovation: Expedited Development and Review Pathways
- Predictability: Meeting PDUFA Goals
- Access: First Cycle Approvals and First in U.S. Approvals
- New Uses of Approved Drugs
- Approved Drugs Expanded for New Pediatric Populations
- Biosimilar and Interchangeable Biosimilar Approvals
- Other CDER Actions
- Conclusion
- Appendix A: CDER’s Novel Approvals of 2022 (in alphabetical order)
- Appendix B: Novel Drug Designations
2022 Biological Approvals
The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks.
Biologics License Applications and Supplements
New BLAs (except those for blood banking), and BLA supplements that are expected to significantly enhance the public health (e.g., for new/expanded indications, new routes of administration, new dosage formulations and improved safety).
- 2022 Biological License Application Approvals
- 2022 Biological License Application Supplement Noteworthy Approvals
- 2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Other Applications Approved or Cleared by the Center for Biologics Evaluation and Research (CBER)
Medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.
Key Resources
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Development & Approval Process (CBER)
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Biologics Products & Establishments
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Transfer of Therapeutic Products to the Center for Drug Evaluation and Research
SOURCE
Approved Cellular and Gene Therapy Products
Below is a list of licensed products from the Office of Tissues and Advanced Therapies (OTAT).
Approved Products
- ABECMA (idecabtagene vicleucel)
Celgene Corporation, a Bristol-Myers Squibb Company- ADSTILADRIN
Ferring Pharmaceuticals A/S- ALLOCORD (HPC, Cord Blood)
SSM Cardinal Glennon Children’s Medical Center- BREYANZI
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company- CARVYKTI (ciltacabtagene autoleucel)
Janssen Biotech, Inc.- CLEVECORD (HPC Cord Blood)
Cleveland Cord Blood Center- Ducord, HPC Cord Blood
Duke University School of Medicine- GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
Organogenesis Incorporated- HEMACORD (HPC, cord blood)
New York Blood Center- HEMGENIX
CSL Behring LLC- HPC, Cord Blood
Clinimmune Labs, University of Colorado Cord Blood Bank- HPC, Cord Blood – MD Anderson Cord Blood Bank
MD Anderson Cord Blood Bank- HPC, Cord Blood – LifeSouth
LifeSouth Community Blood Centers, Inc.- HPC, Cord Blood – Bloodworks
Bloodworks- IMLYGIC (talimogene laherparepvec)
BioVex, Inc., a subsidiary of Amgen Inc.- KYMRIAH (tisagenlecleucel)
Novartis Pharmaceuticals Corporation- LAVIV (Azficel-T)
Fibrocell Technologies- LUXTURNA
Spark Therapeutics, Inc.- MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)
Vericel Corp.- PROVENGE (sipuleucel-T)
Dendreon Corp.- RETHYMIC
Enzyvant Therapeutics GmbH- SKYSONA (elivaldogene autotemcel)
bluebird bio, Inc.- STRATAGRAFT
Stratatech Corporation- TECARTUS (brexucabtagene autoleucel)
Kite Pharma, Inc.- YESCARTA (axicabtagene ciloleucel)
Kite Pharma, Incorporated- ZYNTEGLO (betibeglogene autotemcel)
bluebird bio, Inc.- ZOLGENSMA (onasemnogene abeparvovec-xioi)
Novartis Gene Therapies, Inc.Resources For You
SOURCE
2022 forecast: Cell, gene therapy makers push past regulatory, payer hurdles to set up high hopes for next year
There are five FDA-approved CAR-T treatments for blood cancers and two gene therapies to treat rare diseases now on the market in the U.S. The late-stage pipeline could produce several more cancer CAR-Ts and gene therapies to treat a range of diseases.
One of the biggest races to watch in the cell therapy space will be that between Gilead Sciences’ Yescarta and Bristol Myers Squibb’s Breyanzi, both of which are gunning to move their CAR-Ts into earlier lines of treatment in large B-cell lymphoma (LBCL). At ASH, both companies rolled out impressive data from their trials in the second-line setting, but Gilead could have the upper hand by virtue of its three-year head start in the market, analysts said. Gilead expects to hear from the FDA on a label expansion in the second-line setting in April.
It is almost impossible to set up a conspiracy against big pharma’s abusive practices.Every avenue their high priced lawyers can think of to stop budding conspiracies has been blocked by law where possible. One possible road might be to do research and development in other countries outside US legal juristiction, however most drugs without FDA approval can and are stopped at the border and confiscated even if as in Canada the same drug produced in the US is being manufactured in Canada.Almost certainly Cisplatin is under patent in the US and the patent holder has the right to refuse the use of the drug for any reason they want, including being used in this cluster bomb drug. The manufacturer is almost certainly making huge profits from selling Cisplatin and I doubt they want to see a cheap drug cure many cancers. I guess the only way to go is to try and turn to a country like India.A number of cancer drugs were being sold by US patent holders at wholesale prices that were to high for most Indians. The government of India refused to allow these companies to patent their medicines in India and forced them to license the drugs and much cheaper prices.Most US patents are not operative in India, they can produce US style insulin pumps at a fraction of our cost as they can in China and Vietnam or Mexico. It would be difficult to send these pumps to buyers in the US from India but by shipping them from another country, say Canada or Mexico most would make it past customs. As for Cancer treatment, India and china have some very fine trained biochemist and doctors, who could easily apply many of the immunological treatments against cancer. All arms of the immune system have been used to produce miracle treatments that have cured some patients that were on their death beds.The treatments can be tested carefully in these countries, and improved by any methods including some I have suggested.By advertising in the US to cancer patients that they can inexpensively have these working treatments cheaply as a medical tourist, it is only a matter of time before they will cure the disease wholesale and break the medical industrial complex down. As far as generics that are not being produced here, by setting up a non profit corporation that produces any and all drugs that come off patent as a goal, at the cheapest price less a reasonable markup for cost of manufacture etc. one by one they will end the abuse of not producing or overpricing generics.
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Significance
Successively overcoming a series of biological barriers that cancer nanotherapeutics would encounter upon intravenous administration is required for achieving positive treatment outcomes. A hurdle to this goal is the inherently unfavorable tumor penetration of nanoparticles due to their relatively large sizes. We developed a stimuli-responsive clustered nanoparticle (iCluster) and justified that its adaptive alterations of physicochemical properties (e.g. size, zeta potential, and drug release rate) in accordance with the endogenous stimuli of the tumor microenvironment made possible the ultimate overcoming of these barriers, especially the bottleneck of tumor penetration. Results in varying intractable tumor models demonstrated significantly improved antitumor efficacy of iCluster than its control groups, demonstrating that overcoming these delivery barriers can be achieved by innovative nanoparticle design.
http://www.pnas.org/content/early/2016/03/23/1522080113.full