Glenmark launches anti viral drug Favipiravir at Rs 103 to treat mild COVID-19 cases
New Delhi, June 21: Drug firm Glenmark Pharmaceuticals on Saturday said it has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a price of about Rs 103 per tablet.
The drug will be available as a 200 mg tablet at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said.
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FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19, it added. It is a prescription-based medication, with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, the drug firm said.
When asked about the company's manufacturing capacity of the drug, the drug firm said:
"Considering a minimum of two strips per patient, Glenmark will be able to provide FabiFlu for about 82,500 patients in the 1st month itself. We will be closely monitoring the evolving situation and basis the situation, we will work to scale and meet the healthcare needs of the country."
The company is producing the active pharmaceutical ingredients (API) for the product at its Ankleshwar plant, while the formulation is being manufactured at its Baddi plant. The drug will be available both through hospitals and the retail channel, Glenmark said.
When asked if the company is looking for tie-ups with hospitals for supply of the drug, it said: "Our effort right now is to prioritise manufacturing to ensure FabiFlu is accessible to all patients who need it. Glenmark will certainly make a consideration to support private and public healthcare facilities and arrange for other suitable options as per the need and in time".
The
Mumbai-based
firm
had
on
Friday
received
the
manufacturing
and
marketing
approval
from
the
Drugs
Controller
General
of
India
(DCGI).
"This
approval
comes
at
a
time
when
cases
in
India
are
spiralling
like
never
before,
putting
a
tremendous
pressure
on
our
healthcare
system,"
Glenmark
Pharmaceuticals
Chairman
and
MD
Glenn
Saldanha
said.
The company hopes that the availability of an effective treatment such as FabiFlu will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option, he added.
Glenmark
will
work
closely
with
the
government
and
medical
community
to
make
FabiFlu
quickly
accessible
to
patients
across
the
country,
Saldanha
noted.
The
company
has
developed
the
API
and
the
formulation
for
FabiFlu
through
its
in-house
research
and
development
team,
Glenmark
said.
"We chose to initiate work on Favipiravir, as it has proven in-vitro activity against SARS CoV2 virus, which is the virus responsible for COVID-19.
"Second is it has a wide therapeutic safety margin for COVID-19 at the dose that we administer," Glenmark Pharmaceuticals President India Formulations, Middle East and Africa Sujesh Vasudevan said at an online press conference.
Moreover, it is an oral product and that is a huge benefit especially when the hospital infrastructure is under strain, he added.
Manufacturing and marketing consent has been granted as part of an accelerated approval process, considering the emergency situation of COVID-19 outbreak in India, the drugmaker said.
The approval's restricted use entails responsible medication usage where every patient must have signed informed consent before treatment initiation, it added.
Favipiravir can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms, Glenmark said. It offers rapid reduction in viral load within four days and provides faster symptomatic and radiological improvement.
Favipiravir has shown clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases, it said.
Favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections.
Last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalised adult COVID-19 patients in India.