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.
