Drugmaker Glenmark Pharmaceuticals Limited said on Monday that it had cut the price of its coronavirus disease (Covid-19) drug Favipiravir from Rs103 to Rs75 per pill, which could lower the treatment cost of a 14-day regimen to Rs10,200 from Rs14,000. The antiviral oral drug is sold under the FabiFlu brand name and was released on June 21 on the Indian market. The Drugs Controller General of India (DCGI) has given FabifFlu approval for Covid-19 care under emergency use authorisation, which means that because there are minimal data on the efficacy of the medication on cases of the disease, doctors prescribing the medication would need to seek written informed consent from patients.
“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,” the company said in a statement.
“Glenmark has successfully developed the API and the formulation for FabiFlu® through its own in-house R&D [research and 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 & MHRA–the UK approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also USFDA and MHRA-UK approved.”
USFDA is short for US Food and Drug Administration, and MHRA stands for Regulatory Authority for Medicines and Healthcare Products. Glenmark also reported it had launched a FabiFlu Post Marketing Surveillance (PMS) trial to track closely the drug’s efficacy and safety on 1,000 patients who are prescribed.
“We expect this post-marketing surveillance study to shed more light on the drug’s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring access to the masses. Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that 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.
FabiFlu was initially launched at Rs103 / tab in India. The price is in Russia Rs600 per tablet, in Japan Rs378, in Bangladesh Rs350 and in China Rs215.
“Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu use. Glenmark has also completed the phase 3 clinical trial with Favipiravir (FabiFlu) in mild to moderate Covid-19 patients in India. The trial results will be available shortly,” the company said in its statement.
Glenmark is also performing another phase 3 clinical trial to determine the efficacy of the antiviral drugs Favipiravir and Umifenovir as a combination treatment in adult hospitalized Covid-19 patients in India with mild disease symptoms.