HONG KONG – Telangana, India-based Dr. Reddy’s Laboratories Ltd. has launched Avigan (favipiravir), Fujifilm Holdings Corp.’s potential COVID-19 treatment, in India. Dr. Reddy’s launch comes after the Drugs Controller General of India (DCGI) approved Avigan on July 31 for restricted emergency use to treat mild to moderate COVID-19, after more than 2,100 patients received the drug on a compassionate use basis in Japan.
“Data collated from these patients has demonstrated the efficacy and safety of Avigan in the treatment of mild to moderate COVID-19 patients,” and once the technology transfer from Fujifilm is complete, Dr. Reddy’s will come up with a comprehensive plan for manufacturing the drug, a company spokesman told BioWorld.
Dr. Reddy’s said that the antiviral drug will be available in complete therapy packs of 122 tablets. “Avigan will will be priced at INR99 ($1.33) per 200 mg pill,” the spokesman said.
The price set by Dr. Reddy’s will meet with fierce competition with other lower-priced versions of favipiravir available on the Indian market, such Glenmark Pharmaceuticals Ltd’s Fabiflu, the first version of the drug launched in India, costing around INR75 per pill. Sun Pharmaceutical Ltd.’s Fluguard version is the cheapest, at around INR35 per tablet. However, Dr. Reddy’s offering has a longer shelf life of two years vs. three months for some of its competitors, the company said at a press briefing announcing the launch.
Glenmark received manufacturing and marketing approval for the launch of Fabiflu to treat mild to moderate COVID-19 in late June, with the Mumbai-based company becoming the first pharmaceutical company in India to receive DCGI approval to conduct phase III studies.
Dr. Reddy’s struck a tripartite agreement with Fujifilm Holdings Corp. subsidiary Fujifilm Toyama Chemical Co Ltd. and Dubai-based Global Response Aid (GRA). The agreement gave Dr. Reddy’s the rights to manufacture Avigan, as well as develop, sell, and distribute the drug in India.
Initially developed by Fujifilm Toyama Chemical as an influenza treatment, Japan gave approval for Avigan to be manufactured and sold as an influenza antiviral drug in 2014. The Japanese company is conducting phase III trials in Japan concurrently with phase II trials in the U.S. to evaluate the drug’s safety and efficacy. However, difficulties in recruiting patients for the trial has led to a delay in securing the Japanese Ministry of Health, Labour and Welfare’s approval.
In addition to Avigan, Dr. Reddy’s is also seeking approval in India for a generic of Veklury (remdesivir, Gilead Sciences Inc.), as a potential COVID-19 treatment. Fellow Indian companies Jubilant Pharma Ltd., Zydus Cadila Ltd., BDR Pharmaceuticals International Pvt. Ltd. and Cipla Ltd. are also in line with remdesivir generic candidates. Cipla signed a licensing agreement with Gilead in May to supply remdesivir in 127 countries, including India.
“Avigan has been approved to treat mild to moderate symptoms of COVID-19, while remdesivir has approved for the treatment of severe cases of the virus. We plan to launch remdesivir in the first week of September,” the spokesperson said.
Mylan NV received accelerated approval from the DCGI on July 9 for its restricted emergency use 100 mg remdesivir vial to treat COVID-19 in adults and children with severe cases. It will be released under the Desrem brand name in India, and priced at INR4,800. Meanwhile Stempeutics Research Pvt Ltd. is testing the effectiveness of its Stempeucel therapy to treat COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) due to pneumonia. The company will test Stempeucel’s anti-inflammatory and immunomodulatory properties to help patients with ARDS, which usually occurs in the final stages of COVID-19, with blood not absorbing enough oxygen and leading to death in more than 60% of cases. Stempeutics plans to start a Phase II study soon and is also in the advanced stages of discussion with Indian government authorities, the company said.
India has also kept busy on the vaccine front, with Bharat Biotech International Ltd.’s Covaxin the country’s first homegrown candidate to enter human trials. Bharat won approval from DCGI, as well as the Ministry of Health & Family Welfare, to begin phase I and II trials on the back of positive preclinical studies for safety and immune response in July.
Zydus Cadila is developing a second vaccine, ZyCov-D, having secured Central Drugs Standard Control Organization approval to start human trials. The company aims to complete the first two phases in around three months.
There are more than 3.2 million COVID-19 cases in India as of Aug. 26, according to Johns Hopkins University data. The country has the third-highest number of cases globally, behind the U.S. and Brazil.