HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”

Glenmark filed the product for use in clinical trials with the Drug Controller General of India (DCGI) and became the first pharmaceutical company in India to receive approval to conduct a phase III study in patients with mild to moderate disease caused by the SARS-CoV-2 virus.

Now launched under the name Fabiflu, the drug will be available as a prescription-based medication for INR103 (US$1.35) per tablet, with the recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14.

"This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our health care system,” said Glenn Saldanha, chairman and managing director of Glenmark. “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.

"Fabiflu has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials,” he added. “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."

The company claims most patients exhibiting mild to moderate symptoms can benefit from use of Fabiflu. It cited studies that showed favipiravir demonstrating clinical improvement of up to 88% in mild to moderate cases of COVID-19.

According Glenmark, the drug offers a rapid reduction of viral load within four days and provides faster symptomatic and radiological improvement across a broad age group (20 to older than 90).

Furthermore, it can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease.

Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of both favipiravir and umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.

Based on the news of the favipiravir green light, Glenmark’s stock (BSE:532296) jumped by 27% to close June 22 at INR519.80.

Glenmark developed both the active pharmaceutical ingredient (API) and the formulation for Fabiflu through its own in-house R&D team. It has already begun production of the drug.

Hospitals and retail chemist stores that are nearer to Glenmark’s manufacturing unit in the northern Indian state of Himachal Pradesh could see the drug rolled out by the end of this week. It is expected to be supplied across India by early next week.

Sakshi Sikka, senior pharmaceuticals and health care analyst at Fitch Solutions, said she believes the pandemic has prompted more awareness on the importance of India’s self-sustainability in essential goods.

“The Indian government has aggressively begun implementing a policy to ramp up local output and emerge as an alternative source of generic medicines to China,” Sikka told BioWorld.

Authorities have slowly lifted export restrictions in recent times and have made efforts to support local manufacturers.

“After announcing a $1.8 billion fund for setting up three drug manufacturing hubs, the government has also identified 53 key starting materials and active pharmaceutical ingredients whose output will be boosted on priority,” Sikka said. “These include fever-medicine paracetamol and antibiotics such as penicillin and ciprofloxacin.,”

In addition, the government had also promised a preference in government procurement for local formulations and med tech.

More recently, India has drafted rules for the manufacturing, import and compassionate use of unapproved drugs in the treatment of patients. So other key COVID-19 repurposed drugs could hold a new wave of opportunities for Indian manufacturers.

Gilead Sciences Inc., for instance, has given nonexclusive licenses to four Indian generic pharma companies – Cipla Ltd., Jubilant Pharma Ltd., Hetero Labs Ltd. and Mylan Laboratories Ltd. – to manufacture and distribute generic remdesivir in 127 countries.

The repurposing of existing drugs for the treatment of COVID-19 makes sense as those drugs require less clinical development time, and the majority of the repurposed drugs are available as generics making them affordable compared to novel drugs.

Besides favipiravir and remdesivir, some of the drugs being repurposed in India include hydroxychloroquine, sepsivac, a ritonavir/lopinavir combination, ivermectin, interferon alfa-2b, tocilizumab and itolizumab.

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