BENGALURU (Reuters) – Indian pharmaceutical company Strides Pharma Science Ltd on Thursday received regulatory approval to start clinical trials of antiviral drug favipiravir, which has been touted as a potential treatment for COVID-19.
The Bengaluru-based company has received approval from the Drug Controller General of India to conduct human studies of favipiravir in the country, a Strides executive said on a post-earnings conference call.
Favipiravir is manufactured under the brand name Avigan by a unit of Japan’s Fujifilm Holdings Corp and was approved for use as an anti-flu drug in the country in 2014.
On Wednesday, Kyodo News reported that so far there has been no clear evidence of efficacy for Avigan in treating the novel coronavirus in some clinical trials.
There are currently no approved treatments or vaccines for COVID-19, the disease caused by the new coronavirus, with governments, drugmakers and researchers working on several treatment and vaccine programmes.
Strides will do a bioequivalence study to compare the safety and efficacy of its drug with Avigan, a spokesman said later on Thursday in an emailed statement.
Bioequivalence studies typically help gauge whether non-branded drugs are equally safe and effective to the original branded drug. But the company did not provide any further details about the nature of the studies.
Strides’ announcement comes after Glenmark Pharmaceuticals Ltd said last month it became the first pharma company in the country to get the nod to conduct favipiravir trials. The Mumbai-based company has initiated late-stage clinical trials and expects study results by July or August.
Strides late on Wednesday posted a fourth-quarter consolidated net loss of 2.07 billion rupees ($27.35 million), as it booked a 1.13 billion rupees write down of inventory and other expenses related to withdrawal of ranitidine products.
The company’s shares rose as much as 5.3% to a two-week high in early trade, but pared most of the gains by afternoon and were last up 0.7% at 0827 GMT.
(Reporting by Anuron Kumar Mitra in Bengaluru; Editing by Devika Syamnath, Shounak Dasgupta and Rashmi Aich)