Analysis of FDA Novel Drug Approvals

Shukla, Ajay Kumar; Shukla, Kumar; Mehani, Rekha; Jain, Sanjay Kumar; Maqsood, Sheema

doi:10.13005/bpj/2117

Cited by 2 publications

(1 citation statement)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The increasing trend of biopharmaceutical companies focusing on the discovery, development, and commercialization of biologics is clearly seen based on our analysis. The year 2022 has witnessed the authorization of a large number of novel drugs, similar to previous years [10][11][12]. Noted breakthroughs for 2022 include gene therapies for the management of bladder cancer (Nadofaragene Firadenovec-vncg), relapsed or refractory multiple myeloma (Ciltacabtagene Autoleucel) and hemophilia B (Etranacogene Dezaparvovec-drlb).…”

Section: Discussionmentioning

confidence: 94%

Audit of Usfda Approvals for 2022 From the Perspective of Innovation

DASARAJU,

BAPUGOUDA,

BENDE

et al. 2023

Asian J Pharm Clin Res

View full text Add to dashboard Cite

Objectives: The United States of America (USA) is having a unique place in global innovation within the health-care sector due to the presence of a large number of research-oriented biopharmaceutical companies, contract research organizations, and government research agencies. The aim of this study was to analyze the U.S. Food and Drug Administration (USFDA) approvals for 2022 to increase the awareness among health-care professionals for better clinical decisions. Methods: This was an observational study conducted using online database of USFDA which is accessible freely by the public. The USFDA approvals for 2022 were assessed for new molecular entities (NMEs) including their source and therapeutic area, new indications (NIs) of previously approved drugs, new label extensions (NLEs) of previously approved drugs, new routes of administration (NRAs) of previously approved drugs, and new dosage forms (NDFs) of previously approved drugs. The data obtained were arranged in the tabular form using Microsoft Office Excel 2007. Descriptive statistics was used for analysis. Results: Out of 118 USFDA approvals considered for this study, 25.4% of them were given for NMEs, 27.9% approvals were given for NIs, 33.8% approvals were given for NLEs, 6.7% approvals were given for NRAs, and the remaining 5.9% approvals were given for NDFs. 14 out of 30 NMEs were biologicals and 43.3% of NMEs were indicated for different types of cancer. Conclusion: The USFDA continued to adopt several approaches such as Fast Track process, breakthrough therapy process, accelerated approval process, and priority review process to encourage the research-based biopharmaceutical companies involved in the development of therapeutic options for patients suffering from common as well as rare diseases. More emphasis was given to the approvals of anticancer drugs given the limited options available to treat the cancer in advanced or metastatic stages. However, a lack of discovery and development of antimicrobials with novel mechanism of actions to combat resistance is a cause of concern.

show abstract

Section: Discussionmentioning

confidence: 94%

Audit of Usfda Approvals for 2022 From the Perspective of Innovation

DASARAJU,

BAPUGOUDA,

BENDE

et al. 2023

Asian J Pharm Clin Res

View full text Add to dashboard Cite

show abstract

Pharmacological Profile of Novel Anti-cancer Drugs Approved by USFDA in 2022: A Review

Sangwan¹,

Sharma²,

Goyal³

2024

CMM

View full text Add to dashboard Cite

Background: For any drug molecule, it is mandatory to pass the drug approval process of the concerned regulatory authority, before being marketed. The Food and Drug Administration (FDA), throughout the year, approves several new drugs for safety and efficacy. In addition to new drug approvals, FDA also works on improving access to generic drugs, aimed to lower the cost of drugs for patients and improve access to treatments. In the year 2022 twelve new drug therapies were approved for managing varying cancers. Methods: This manuscript is focused to describe the pharmacological aspects including therapeutic uses, mechanisms of actions, pharmacokinetics, adverse effects, doses, indication for special cases, contraindications, etc., of novel FDA-approved anticancer drug therapies in the year 2022. Result: FDA has approved about 29% (11 out of 37) novel drug therapies for varying types of cancers such as lung cancer, breast cancer, prostate cancer, melanoma, leukemia, etc. The Center for Drug Evaluation and Research CDER has reported that 90% of these anticancer drugs (e.g. Adagrasib, Futibatinib, Mirvetuximabsoravtansine-gynx, Mosunetuzumab-axb, Nivolumab and relatlimab-rmbw, Olutasidenib, Pacritinib, Tebentafusp-tebn, Teclistamab-cqyv, and Tremelimumab-actl) as orphan drugs and recommended to treat rare or uncommon cancers such as non-small cell lung cancer, metastatic intrahepatic cholangio-carcinoma, epithelial ovarian cancer, follicular lymphoma, metastatic melanoma, metastatic uveal melanoma, etc. CDER has identified six anticancer drugs (e.g. Lutetium (177Lu)vipivotidetetraxetan, Mirvetuximabsoravtansine-gynx, Mosunetuzumab-axb, Nivolumab and relatlimab-rmbw, Tebentafusp-tebn, Teclistamab-cqyv) as first-in-class drugs i.e. drugs having different mechanisms of action from the already existing ones. The newly approved anticancer drugs shall provide more efficient treatment options for cancer patients. Three FDA-approved anticancer drugs in the year 2023 are also briefly described in the manuscript. Conclusion: This manuscript, describing the pharmacological aspects of eleven anticancer novel drug therapies approved by the FDA, shall serve as a helpful document for cancer patients, concerned academicians, researchers, and clinicians, especially oncologists.

show abstract

Analysis of FDA Novel Drug Approvals

Cited by 2 publications

References 0 publications

Audit of Usfda Approvals for 2022 From the Perspective of Innovation

Audit of Usfda Approvals for 2022 From the Perspective of Innovation

Pharmacological Profile of Novel Anti-cancer Drugs Approved by USFDA in 2022: A Review

Contact Info

Product

Resources

About