MUMBAI: In an indication of innovation in pharmaceuticals for Covid, Mumbai-based Glenmark may become the first company in India to offer an anti-retroviral, Favipiravir, from a class of drugs which has shown promise, and is being used as a potential treatment for the virus. Glenmark has developed anti-retroviral (ARV) drug, Favipiravir, which has shown positive results globally, and has applied for regulatory approval for trials in India, sources told TOI.
Faviparir has demonstrated good results against influenza viruses, including those that are oseltamivir-resistant, and has been approved in Japan and China.
Globally, it is either anti-malarial drug hydroxychloroquine, or anti-retrovirals/anti-virals like Favipiravir, Remdesivir and Lopinavir, that are increasingly being used for Covid treatment.
Japanese company Fujifilm sells the drug, Favipiravir, under the brand, Avigan, which has been approved in Japan since 2014 to treat influenza, and other viral strains that don’t respond to other therapies. The drug which was earlier used to treat Ebola, became off-patent last year, which implies generic versions can possibly be launched anywhere in the world.
When contacted, Glenmark confirmed it has submitted its application to Drugs Controller General of India (DCGI) for marketing approval of Favipiravir.
Drugs which have shown promise, and are now part of a global trial, include antiviral drug Remedesivir, a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and antimalarial drug chloroquine. ICMR recently advised the use of HCQ for prevention among high risk categories — healthcare workers and relatives of confirmed patients. Earlier, DCGI had approved ‘restricted use’ of a combination of anti-HIV drugs, lopinavir and ritonavir’, for treating Covid-19 patients.
Glenmark has developed the API in-house, which is believed to have been a big challenge as many firms are still trying to do so.
Once the regulatory approval is in place, the company will conduct trials on 60-100 patients, and will launch the drug.
Remidasvir, manufactured by Gilead Sciences, and Favipiravir are the two drugs that have not been approved in India yet. Of this, the former cannot be produced here without US company’s nod as it is patented. Other ARVs are manufactured by Cipla, Aurobindo Pharma and Mylan.
Earlier, Dr YK Hamied, promoter of Cipla, had told TOI in an interview that the company is initiating development of raw materials of promising anti-viral compounds favipiravir, remidesivir and bolaxavir, with the help of government laboratories, while another firm, Lasa SuperGenerics, is also working on favipiravir molecule.
