Glenmark launches Covid-19 drug at Rs 103 per tablet. Drug will be available both through hospitals and the retail channel.
HEALTH DESK
Pharma company Glenmark Pharmaceuticals today 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.
The antiviral medication was developed in Japan and subsequently approved for use among influenza patients. Favipiravir is among the drugs under trial for Covid-19 treatment along with Ebola drug remdesivir, a combination of HIV drugs lopinavir and ritonavir, as well as a combination of the latter two drugs with Interferon beta.
Currently, the drug is the subject of at least 18 clinical trials involving more than 3,000 patients across India, USA, Canada, Italy, China, France, UK and other countries.
Early trials on the drug in China, involving 340 patients, produced encouraging outcomes in Wuhan and Shenzhen.
Glenmark becomes the first pharmaceutical company in India to receive regulatory approval for oral antiviral Favipiravir, for the treatment of mild to moderate COVID-19
• Manufacturing and marketing approval granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India
• The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation
• Favipiravir shows clinical improvements of up to 88% in COVID-19, with rapid reduction in viral load by 4 days
• Clinical improvement 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
• Glenmark to market the antiviral under the brand name ‘FabiFlu®’
Mumbai, India; June 20, 2020: In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, today announced the launch of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.
Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage2 with clinical improvement noted across age groups 20 to >90 years.3 Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms.3 It offers rapid reduction in viral load within 4 days1,4 and provides faster symptomatic and radiological improvement.1,4,5 Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.3
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team. Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our healthcare system. We hope 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, “FabiFlu® has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country.”
Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. The drug will be available as a prescription-based medication for INR 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
Earlier 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 hospitalized adult COVID-19 patients in India.