COVID 19 medicine FabiFlu approved in India
COVID 19 medicine FabiFlu approved in India

A breakthrough achieved in fight against COVID-19

FabiFlu — Favipiravir manufactured by Glenmark, has received approval for the manufacture and marketing of the antiviral drug. Favipiravir is one of the medicines that is being explored as a potential treatment for Covid-19. It is the first cure to be approved and commercially available for the treatment of Covid-19 virus.

Will this work in all COVID 19 Cases?

Glenmark has said that the drug is advised for mild to moderate Covid-19 cases.
To address urgency of rising Covid-19 cases, Drug Controller General of India fast-tracked permission to Glenmark Pharmaceuticals to manufacture & market favipiravir tablets.

Cost

■ The drug is priced at X3,500 for a pack of 34 tablets

■ RS 103 per tablet.
■ It will be available in retail chemist stores and hospitals by next week.

Can you take FabiFlu by yourself?

■ NO , IT IS A PRESCRIPTION DRUG . Also, Doctors will need a patient’s consent before prescribing the drug. According to Glenmark, the drug can be used in Covid-19 patients with co morbid conditions such as diabetes and heart disease, who have mild to moderate symptoms of the disease.
“It offers rapid reduction in viral load within 4 days and provides faster symptomatic improvement.”

How effective is Favipiravir?

• Studies from Japan, Russia and China have shown positive results. • Favipiravir shows clinical improvements of up to 88% highest in rate in COVID-19, with rapid reduction in viral load by 4 days

• Clinical refinement noted across age groups 20 to 90 years, including in patients with co-morbid conditions like diabetes and heart disease suffering from mild to moderate COVID-19.

Currently, the Medicine is the subject of at least 18 clinical trials involving more than 3,000 patients across USA, Canada, Italy, China, France, India, UK and other countries

Are other nations using Favipiravir too?

■ Yes
■ Favipiravir has so far been approved for experimental use among Covid-19 patients by the regulators of Italy and China.

■ Commercially launched in Bangladesh.

How does Favipiravir stop SARS COV2?

The drug works by short-circuiting the reproduction mechanism of certain RNA (India,) viruses such as influenza.
It hinders the activity of “RNA-dependent RNA polymerase (RdRp)” of SARS CoV2.
This leads to the blocking of viral replication and thus reduces the viral and severity of the disease.

Is it fully tested yet?

• Glenmark has stated that it’s phase three clinical trials using antiviral drug Favipiravir for Covid-19 patients is showing early promising results.
• The DCGI has approved the drug for restricted emergency use, even as the results are yet to be declared.
The common stages of the development cycle of a vaccine are

  1. Exploratory stage
  2. Pre-clinical stage
  3. Clinical development
  4. Regulatory review and approval
  5. Manufacturing
  6. Quality control
    • Glenmark has stated that it’s phase three clinical trials using antiviral drug Favipiravir for Covid-19 patients is showing early promising results.
    • The DCGI has approved the drug for restricted emergency use, even as the results are yet to be declared.

Post-marketing surveillance trials

Once a Medicine enters public use, researchers monitor several thousand volunteers to spot side effects not seen in earlier trials and to track how well the vaccine works over extended periods of time.

Are there any risks?

■ In Japan, Avigan’s use has been strictly controlled by the government due to potential risk for teratogenicity.

■ Teratogen = a drug or other substance capable of interfering with the development of a foetus, causing birth defects.
■ The mechanism that makes Avigan effective against viruses also makes it destructive to the rapid cell growth of foetuses.

Game Changer?

• Oral tablets

• Easy to administer

• Can be taken at home (with a prescription)

• Manufactured in India

Which other drugs are in clinical trials in India ?

Favipiravir and Umifenovir are the drugs approved by Drug Controller General of India (DCGI) for clinical trials to treat Covid-19, at Council of Scientific and Industrial Research (CSIR). Now in clinical trials
• ACQH

• Umifenovir (Arbidol)

• Mycobacterium W (anti-leprosy drug)

COVID 19 medicine FabiFlu approved in India COVID 19 medicine FabiFlu approved in India