Glenmark Pharmaceuticals on Monday announced that it has reduced the selling price of its coronavirus disease (Covid-19) drug Favipiravir from Rs 103 to Rs 75 per tablet that could significantly lessen the cost for a 14-day regimen from Rs 14,000 to Rs 10,200.

The antiviral oral drug is marketed under the brand name FabiFlu and was formally launched in the country on June 21.

The Drugs Controller General of India (DCGI) granted it approval for Covid-19 treatment under emergency use authorisation, which means since there is limited data available on the medicine’s performance on Covid-19 positive cases, doctors prescribing it would have to document the written consent of a patient.

“The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API (active pharmaceutical ingredient) and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country,” said the company in a statement.

“Glenmark has successfully developed API and the formulation for FabiFlu through its own in-house R&D (research & development) team within the country, ensuring self-reliance with regard to long-term production and manufacturing. The API is manufactured at the Gujarat production facility which is USFDA (United States Food and Drug Administration) and MHRA-UK (Medicines and Healthcare products Regulatory Agency – the United Kingdom) approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also USFDA and MHRA-UK approved,” it added.

The company also announced that it has started a post-marketing surveillance (PMS) study on FabiFlu in a bid to closely monitor the efficacy and safety of the drug in 1,000 Covid-19 patients that are prescribed the drug as part of an open-label, multicentre, single-arm study.

“We expect this PMS study to shed more light on the drug’s clinical effectiveness and safety in a large section of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer effective treatment for Covid-19 patent and also ensure accessibility to the masses. Our internal research shows us that we launched FabiFlu in the country at the lowest market cost, as compared to the cost of Favipiravir in other countries, where it is approved. This further price reduction will make it even more accessible for patients across the country,” said Alok Malik, senior vice president, and head – India business, Glenmark Pharmaceuticals Ltd.

Initially, FabiFlu was launched in India at Rs103 a tablet, while its equivalent price is higher in other countries such as Russia (Rs 600), Japan (Rs 378), Bangladesh (Rs 315), and China (Rs 215).

“Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. Glenmark has also completed the phase-III clinical trial with Favipiravir (FabiFlu) in mild to moderate Covid-19 patients in India. The trial results will be available shortly,” said the company in a statement.

Glenmark is also conducting another phase-III clinical trial to evaluate the efficacy of two antivirals drugs, Favipiravir and Umifenovir, as a combination therapy in moderate hospitalised adult Covid-19 patients in the country.