FabiFlu | Latest Covid-19 Vaccine to be Developed using Favipiravir Phase-3 Clinical trials
GS Paper III: Science and Technology – developments and their applications and effects in everyday life Achievements of Indians in science & technology; indigenization of technology and developing new technology.
Context: The Glenmark Pharmaceuticals has initiated Phase-3 clinical trials in India on antiviral tablet Favipiravir in order to develop effective vaccine for COVID-19.
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About FabiFlu and Favipiravir use in COVID-19 Phase-3 Clinical Trials
- Favipiravir, sold under the brand name Avigan, is an antiviral medication used to treat influenza in Japan.
- It became a generic drug in 2019 and is also being studied to treat a number of other viral infections.
- It is a generic version of the Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, which is a subsidiary of Fujifilm Corporation.
- The Favipiravir has shown activity against influenza virus and has been approved in Japan for the treatment of novel influenza virus infections.
- The molecule if commercialized, will be marketed under the brand name “FabiFlu” in India.
- It is also be noticed that the Glenmark is the first company in India to initiate Phase-3 clinical trials on Favipiravir for COVID-19 patients in India.
- An approval has already been received from the India’s drug regulator DCGI in April 2020.
- The company has developed the Active Pharmaceutical Ingredients (APIs) and the formulations for the product through its in-house R&D team.
What you need to know about Phases of Clinical Trials?
Clinical trials involving new drugs are commonly classified into four phases. Individual trials may encompass more than one phase. The drug development process will normally proceed through all four phases over many years.
- If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.
- Phase IV are ‘post-approval’ studies.
- The entire process of developing a drug from preclinical research to marketing can take approximately 12 to 18 years and often costs well over $1 billion.
PHASE I CLINICAL TRIALS
- These trials are the first stage of testing in human subjects.
- They are designed to test the safety, side effects, best dose, and formulation method for the drug.
- Normally, a small group of 20–100 healthy volunteers will be recruited.
- These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff.
PHASE II CLINICAL TRIALS
- Phase II trials are performed on larger groups (100–300)
- These are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients.
- When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
- Phase II clinical programs historically have experienced the lowest success rate of the four development phases.
PHASE III CLINICAL TRIALS
- This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice.
- Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied).
- These are aimed at being the definitive assessment of how effective the drug is, in comparison with current ‘gold standard’ treatment.
- Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.
- This is sometimes called the “pre-marketing phase” because it actually measures consumer response to the drug.
- While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug’s safety and efficacy, in order to obtain approval from the appropriate regulatory agencies.
- As of 2010, about 50% of drug candidates either fail during the Phase III trial or are rejected by the national regulatory agency.
PHASE IV CLINICAL TRIALS
- Phase IV trial is also known as postmarketing surveillance trial, or informally as a confirmatory trial.
- This involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.
- Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons.
- The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.
- Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses.
- The minimum time period mandatory for Phase IV clinical trials is 2 years.
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PRELIMS Background Bites
Drugs Controller General of India (DCGI) is a department of the Central Drugs Standard Control Organization of the Government of India. It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
Drug Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI sets standards for manufacturing, sales, import, and distribution of drugs in India. On 14 August 2019, VG Somani was appointed as Drug Controller General of India (DCGI).
- With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules.
- Out of four Classes of medical devices from Class A to Class D, DCGI will be the direct licensing authority for Class C and Class D devices
- It will also coordinate licensing for Class A and B devices through State drug controllers, who will act as State Licensing Authority or SLA.
The central government have established 4 zonal offices of Central Drugs Standard Control Organisation at Mumbai, Kolkata, Chennai, and Ghaziabad.
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