By David Wallace 11 May 2021
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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.
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.
COVID-19 therapeutic management guidelines already include favipiravir in Russia, Japan and Saudi Arabia, a company presentation said. (Also see "Coronavirus Update: Moderna Progesses To Phase II, Russia Approves Homegrown Antiviral" - Scrip, 1 Jun, 2020.)
It also noted that the antiviral has been seen compassionate use in Japan, where it has been given to over 2,000 patients, with reports of “high recovery rates observed at both seven and 14 days of therapy in both mild and moderate patients." Last month, Japan’s health ministry said more time was required to fully confirm safety and efficacy of favipiravir in COVID-19. (Also see "Coronavirus Update: Sinovac Gets $15m Towards CoronaVac Phase II, Remdesivir Early Access In UK" - Scrip, 27 May, 2020.)
Nevertheless, news of the Indian approval set social media abuzz, with some distinctly polarized views. Some senior physicians asked whether there were “hard outcomes” to show and that doctors and patients might flock to access the product “given the desperate situation.”
Others noted that the drug is already formally approved in countries like Japan for influenza, with its safety profile well documented. “I support emergency use till RCT [randomized controlled trial] results are out," Dr T R Raju, an alumnus of the Jawaharlal Institute of Postgraduate Medical Education and Research and John Curtin School of Medical Research of the Australian National University, tweeted on 21 June. Dr Raju also urged the Indian government to spell out its stand on the drug in view of all the scrutiny on social media.
Fujifilm Toyama Chemical's favipiravir has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections and Japan recently indicated plans to provide free supplies to 38 countries through the United Nations.
Favipiravir is off patent and has been targeted by several generic firms including Cipla and Strides Pharma Science in India as a potential treatment for COVID-19. Strides has exported the product to Gulf Cooperation Council countries while others including Bangladesh’s Beximco have already launched favipiravir (sold as Viraflu) domestically.
There have been some suggestions that favipiravir may still be covered by specific process patents in India, though Glenmark clarified to Scrip that the compound patent covering the antiviral expired in India and other countries in August last year.
“So there is no issue with regard to process infringement. We have, however, filed a patent application in India for the combination of favipiravir and umifenovir [another antiviral] on 21 May 2020,” Glenmark specified to Scrip. The company recently received regulatory clearance to initiate clinical trials for a combination of favipiravir and umifenovir in COVID-19 patients in India.
Other combinations of favipiravir are also being studied internationally. For instance, The University of Tokyo Hospital is conducting a trial with a combination of the anticoagulant nafamostat and favipiravir in SARS-CoV-2-positive patients developing pneumonia.
Glenmark also underscored that it had demonstrated its end-to-end capabilities for favipiravir, successfully developing both the active pharmaceutical ingredient (API) and the formulation for FabiFlu in-house.
The API is being made at the firm’s Ankleshwar plant, while formulation manufacturing is being undertaken at Glenmark’s facility in Baddi. “Having internally developed the API and the formulations for the product, we believe we are well positioned to scale and meet the healthcare needs of the country,” the company stated.
Significantly, the Indian go-ahead for favipiravir came almost in tandem with the regulatory clearance in the country for remdesivir, the other investigational antiviral currently in the global spotlight as a potential treatment for COVID-19. On 21 June, Gilead Sciences licensees Hetero Drugs Ltd. and Cipla said they had received approval from the Drugs Controller General of India for their remdesivir formulations in India.
Gilead recently sealed non-exclusive voluntary licensing agreements with five generic firms in India and Pakistan, including Hetero and Cipla, to manufacture remdesivir for distribution in 127 countries. (Also see "Gilead Licenses Remdesivir To Five Firms" - Generics Bulletin, 13 May, 2020.)
A version of this story first appeared in our sister publication, Scrip.
By David Wallace 11 May 2021
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