US FDA norms on Clinical Pharmacogenomics may provide clear rules for new drug devpt
The US Food and Drug Administration (FDA) has now issued the guidance for Industry on Clinical Pharmacogenomics which refers to a Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for labelling.
The US Food and Drug Administration (FDA) has now issued the guidance for Industry on Clinical Pharmacogenomics which refers to a Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for labelling.
The guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug’s pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety.
The norms provide recommendations on when and how genomic information should be considered to address questions arising during drug development and regulatory review.
According to pharma companies like Biocon and Micro Labs which are engaged in new drug development efforts, a guidance will allow to strictly adhere to norms and ensure that speedy clearances are sought.
The application of Pharmacogenomics approaches during drug development is an evolving process that begins with discovery and continues through confirmation of clinical efficacy and safety outcomes. The focus of this guidance, however, is to provide advice on general principles of study design, data collection, and data analysis in early-phase trials.
The document guidance does not address trial design or statistical analysis considerations for later-phase, randomized, controlled clinical trials that are intended to draw definitive conclusions about treatment effects in a genomic subgroup (e.g., enrichment designs, adaptive enrichment designs, simultaneous hypothesis testing overall and within subgroups), or co-development of a drug and in vitro diagnostic, stated the regulatory authority.
The considerations provided are more relevant for exploratory and observational studies intended to generate genomic hypotheses that may then be tested in prospectively designed phase III trials. For instance, early-phase data on genomic-dependent dosing or efficacy, even when not definitive, can provide guidance on dosing or patient selection in later-phase trials, or inform the strategy for further collection of genetic and related biomarker data in later controlled trials, said the regulatory authority.
Genetic differences between individuals can affect virtually all aspects of a disease and its treatment, including the rate of disease occurrence. The risk of disease progression or recurrence, the drug most likely to provide benefit along with the therapeutic dose, the nature and extent of beneficial responses to treatment and the likelihood of drug toxicity are also provided.
Drug product labelling has increasingly included information obtained during drug development on the treatment effect in a subset of patients with a particular genetic/ genomic status, on altered risk - benefit balance in genetic sub-groups, or on the need to genotype to guide dosing.
Drug product labelling has also been revised after approval, based on post market experience, to include Pharmacogenomics information that can inform the benefit - risk relationship or allow dosing of the drug to be adjusted for individuals. “It is hoped that ascertainment of genomic information throughout drug development will enable earlier discovery of clinically important genomic differences,” said the regulator.
Pharmacogenomics studies can contribute to a greater understanding of inter-individual differences in the efficacy and safety of investigational drugs. This research depends on the collection and use of biological samples to generate data.
For early assessment in early-phase clinical studies, Pharmacogenomics has to identify the populations that should receive lower or higher doses of a drug. It needs to classify responder populations based on phenotypic, receptor, or genetic characteristics. Further, it has also insisted to look for high-risk groups which report serious adverse drug reactions.
Labelling should include information on Pharmacogenomics only if it is useful to inform prescribers about the impact of drug on particular genotype where a test is required before actual drug administration.
Related News
-
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance