Favipiravir is the first drug approved by DCGI for COVID-19 Patients in India- Know more

Glenmark has filed a product for a clinical trial with India’s Drug regulatory body DCGI and became the first company in India to receive approval for conducting Covid-19 patients treatment. The drug Favipiravir has been tested successfully and it will be available in the upcoming weeks.

Many Pharmaceutical companies have launched generic versions of Remdesivir and Favipiravir for Covid-19 treatment, experts said that the results have shown a positive impact on the patients. The pharmaceutical companies have received approval to manufacture and market this drug meanwhile, Glenmark has launched this drug under the brand name FabiFlu, an oral medication.

According to the press release, Glenmark has issued approval on 20 June and the company has developed the ingredients successfully in its own in-house.

FabiFlu is the first approved oral medication for Covid-19 patients, after getting approval from DCGI this antiviral drug will be marketed to different parts of the country.  The approval has come at the right time when Covid-19 cases are increasing like never before.

What is Favipiravir’s oral medication?

This antiviral medication was first developed in Japan for treating Influenza, now it is tested on more than 15 clinical trials for Covid-19 till now most of the studies reflect positive results.

This drug is said to control the effects of Covid-19 patients within four days. It has shown more than 80% of clinical improvements in Covid-19 patients with mild to moderate symptoms. This medicine will be administered to patients between 18-75 years of age.

Glenmark Pharma said that Covid-19  patients with co-related conditions such as heart diseases or diabetes can also have this medicine. Fabiflu 200 mg is a prescription based medication, the recommended dose is 200 mg daily twice and it will be followed by 800 mg up to the next 14 days.

Why does Favipiravir work effectively?

This drug has efficacy as it works by preventing the virus from duplicating its genetic material. This drug showed strong inhibitory action against fever and cough. RNA polymerase or RNA dependent on most of the viruses with RNA genome.  It proved as effective medication during flu.

As per medical experts, Favipiravir is the game-changer for Covid-19 patients.  This medication has to be given in the early days of the treatment and it can be given in the form of a tablet.

Initially, Favipiravir 200 mg will be available at the hospitals and retail stores. The price for 1 strip will cost Rs 3500 as Glenmark said.

The improvement was shown in Covid-19 patients with Favipiravir 200mg tablet 

Glenmark said that Favipiravir has shown improvements in the Covid-19 patients with a rapid boost in the recovery. This drug was tested on Indian patients to know the drug’s potency and standard safety care of patients. This study has enrolled more than 100 patients and results are yet to be disclosed.

This drug has shown rapid recovery and relieved the patients from extreme fever and cough.

Presently Glenmark’s priority is to capture the Indian market and later it will export the drug.

Read:- Branded Medication vs Generic Medication vs Branded Generic

WHO Temporarily Pauses Hydroxychloroquine Trials Owing to Safety Concerns

Hydroxychloroquine trial has come to a standstill while WHO is reviewing the data collected from the ongoing trials and studies on the benefits and harms of hydroxychloroquine sulfate, an anti-malaria drug in the treatment of COVID-19.

During a press conference, WHO’s Director-General Tedros Adhanom said, "The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally."

In the international solidarity trial, WHO has been studying the efficacy of various medications like remdesivir, hydroxychloroquine, lopinavir ritonavir in fighting off COVID-19.
As per Lancet observational study on May 22, over 100,000 coronavirus patients who were treated with hydroxychloroquine showed no signs of recovery and were even at a higher risk of death and irregular heartbeats.

The final word on the benefits and side effects of hydroxychloroquine will be put out once the Data Safety Monitoring Board has reviewed the available data and evidence.
For the patients who were randomized to HCQ treatment will continue to take the medicine until they finish their course of therapy. This drug is considered to be safe to use on patients with malaria or autoimmune diseases.

The medical community also stands divided in this matter. While some countries are reporting more evidence on the potential harms and limited benefits of hydroxychloroquine, countries like Brazil, the US, and India are continuing with its widespread use. US President Donald Trump sought supplies from India and uses HCQ as a preventive therapy against coronavirus.

On the same day as the Lancet study was published, the clinical research body of India ICMR explained the use of hydroxychloroquine as prophylaxis against COVID-19. They recommended the use of HCQ for frontline workers, healthcare workers, and policemen as a preventive therapy. However, keeping the contraindications in mind, they suggested one EPG during the course of therapy. ICMR also presented three observational studies from government hospitals showing that the healthcare workers who took HCQ had fewer chances of developing SARS-CoV-2 infection in comparison with those who were not on prophylaxis.

WHO has warned physicians against the use of unproven medication medications on the COVID-19 patients and also cautioned people not to use any medications either.

However, WHO has not prohibited the countries from using such drugs. Every country is free to act how they want but must follow the guidelines of their respective health ministries.

There are probably more than 150 case studies and trials going worldwide to determine the efficacy of hydroxychloroquine sulphate in COVID-19 treatment.

As a part of WHO’s international Solidarity Trial, more than 3500 patients have been recruited from over 17 countries. Around 400 hospitals are recruiting patients daily to perform the trial. The largest trial is going in the United Kingdom that is examining the possible effects of HCQ on the death risk in COVID-19 patients.

The final decision of the Data Safety Monitoring Board on the use of hydroxychloroquine may be out by mid -June.

Read:- Brief on Hydroxychloroquine sulphate

Favipiravir is on trial for the treatment of COVID 19:- A brief Discussion

In 2014 the Favipiravir, an antiviral was approved for medical use in Japan, which sold under the brand name Avigan. This antiviral medication is indicated for the treatment of influenza in Japan. Apart from this, the medicine is also being studied in order to the treatment of several other viral infections. The indication of Favipiravir is for novel influenza instead of seasonal influenza.
Novel influenza is basically strains, that are responsible in order to cause more severe disease. So far, the probability of resistance developing appears low.

In order to the experimental treatment of the emergent COVID-19, in February 2020 Favipiravir was being studied in China. In Japan, trials of this medication are also being planned.

In China, Favipiravir has been approved in order for use in the clinical trials of coronavirus disease in 2019.

After China, Italy also approved the drug for experimental use against COVID-19 in March 2020. These trials were conducted in the three major regions that were affected by the pandemic. The IPA (Italian Pharmaceutical Agency), has reminded the public that the existing evidence in support of this drug is scant and preliminary.

On 20'th April 2020, three hospitals in Massachusetts made a decision to study.  A trial in London, UK, going to be held by early May 2020.

According to the statement of Glenmark Pharmaceuticals, they have received the Indian drug controller's approval in order to conduct the clinical trials on Favipiravir. This antiviral drug is being used for treating Covid-19 in some countries across the world. Approximately 150 patients will be enrolled for this clinical trial and every participant's going to receive favipiravir plus standard supportive care or only standard supportive care. In trials, the duration of the treatment is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.

Fujifilm Toyama Chemical confirmed that the medication has potential against influenza viruses. In Japan, Avigan has been approved for use in the treatment of novel influenza virus infections. On the other hand, Fujifilm has started the phase-3 trial and increased the production of this drug.
The Executive Vice President of Global R&D, Glenmark Pharmaceuticals Limited, Mr. Sushrut Kulkarni stated as, "Glenmark has been all set in order to initiate the immediate clinical trials on Favipiravir on COVID-19 patients in India. These clinical trials will help by showing the efficacy of this molecule on the COVID-19 patients.” He also added, "if the outcome of these clinical trials will be effective and positive, favipiravir could become a potential treatment for Covid-19 patients.

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