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Glenmark Pharmaceuticals appears to have stolen a march over its
peers after it received regulatory clearance in India for and launched
its version of favipiravir, the antiviral currently being evaluated as
part of treatment options for COVID-19 in several countries including
Japan.To get more news about 259793-96-9, wisepowder official website is the best place for you.
Glenmark’s product, to be sold as FabiFlu, has received emergency use authorization in India for the treatment of mild to moderate COVID-19, the disease caused by the coronavirus. The manufacturing and marketing go-ahead was granted as part of an accelerated approval process, which takes into account disease severity, rarity and the availability of alternative treatments, the firm explained in a presentation. Patients will be required to provide informed consent before initiation of treatment.
Glenmark said the approval terms also require the company to submit updated safety and efficacy data to India’s drug regulator on “a periodic basis. Further, we will be submitting postmarketing surveillance of the first 1,000 patients who access the drug. The CDSCO [Central Drugs Standard Control Organization] has given us three months to submit a final clinical trial report, which we expect to complete in about four weeks from now,” Glenmark told Generics Bulletin sister publication Scrip.
Glenmark’s chair and managing director Glenn Saldanha noted that since FabiFlu is orally administered, 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,” Saldanha added.
The product, which acts as an RNA polymerase inhibitor, is available as a 200mg tablet and priced at INR3,500 ($45.90) for a pack of 34 tablets. While pricing may appear rational, some industry experts said that treatment entails a significant pill burden, given the day-one dose requirement of 1,800mg twice-daily and then 800mg twice-daily from day two onwards, for a maximum 14 days.
“This would imply 18 tablets are to be taken on day one, and that’s a challenge, but higher-dose tablets may be on the anvil,” one expert told Scrip.Glenmark has been conducting Phase III trials with favipiravir as a monotherapy option for COVID-19. The study evaluated efficacy and safety plus standard of care versus standard of care alone in mild to moderate disease and involved 150 patients at 11 sites across India.
On how the clinical improvement/recovery rate in the study compared to other global trials, the Mumbai-based firm said that, globally, COVID-19 patients treated with favipiravir have shown positive outcomes such as reduced clinical symptoms and quicker disease recovery within one week. “Glenmark’s clinical trial findings are in line with global data, with most patients showing clinical improvements within the first seven days of treatment initiation,” the company said.
There is significant global development activity around favipiravir for COVID-19 and Glenmark highlighted that around 18 clinical trials involving over 3,000 subjects are underway in countries including India, the US, Canada, Italy, China, France and the UK.
Glenmark’s product, to be sold as FabiFlu, has received emergency use authorization in India for the treatment of mild to moderate COVID-19, the disease caused by the coronavirus. The manufacturing and marketing go-ahead was granted as part of an accelerated approval process, which takes into account disease severity, rarity and the availability of alternative treatments, the firm explained in a presentation. Patients will be required to provide informed consent before initiation of treatment.
Glenmark said the approval terms also require the company to submit updated safety and efficacy data to India’s drug regulator on “a periodic basis. Further, we will be submitting postmarketing surveillance of the first 1,000 patients who access the drug. The CDSCO [Central Drugs Standard Control Organization] has given us three months to submit a final clinical trial report, which we expect to complete in about four weeks from now,” Glenmark told Generics Bulletin sister publication Scrip.
Glenmark’s chair and managing director Glenn Saldanha noted that since FabiFlu is orally administered, 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,” Saldanha added.
The product, which acts as an RNA polymerase inhibitor, is available as a 200mg tablet and priced at INR3,500 ($45.90) for a pack of 34 tablets. While pricing may appear rational, some industry experts said that treatment entails a significant pill burden, given the day-one dose requirement of 1,800mg twice-daily and then 800mg twice-daily from day two onwards, for a maximum 14 days.
“This would imply 18 tablets are to be taken on day one, and that’s a challenge, but higher-dose tablets may be on the anvil,” one expert told Scrip.Glenmark has been conducting Phase III trials with favipiravir as a monotherapy option for COVID-19. The study evaluated efficacy and safety plus standard of care versus standard of care alone in mild to moderate disease and involved 150 patients at 11 sites across India.
On how the clinical improvement/recovery rate in the study compared to other global trials, the Mumbai-based firm said that, globally, COVID-19 patients treated with favipiravir have shown positive outcomes such as reduced clinical symptoms and quicker disease recovery within one week. “Glenmark’s clinical trial findings are in line with global data, with most patients showing clinical improvements within the first seven days of treatment initiation,” the company said.
There is significant global development activity around favipiravir for COVID-19 and Glenmark highlighted that around 18 clinical trials involving over 3,000 subjects are underway in countries including India, the US, Canada, Italy, China, France and the UK.