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.
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.
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.
India on Saturday saw
another record spike of 14,516 new COVID-19 cases in a single day, pushing the
tally to 3,95,048, while the death toll rose to 12,948 with 375 new fatalities,
according to Union Health Ministry data.
.png)
.jpg)
.gif)
