DCGI on Sunday had sought clarification from Glenmark over its alleged "false claims" about the use of FabiFlu on COVID-19 patients with comorbidities and also over the "pricing" of the drug, after receiving a complaint from a Member of Parliament.
Glenmark Pharmaceuticals on Tuesday said its generic version ofantiviral drug Favipiravir, FabiFlu, is more economical and effective than other drugs available in the market approved for emergency use for treatment of COVID-19. The company was reacting to a letter sent by India’s drug regulator DCGI seeking clarifications on the concerns raised and allegations made by a Member of Parliament.
DCGI on Sunday had sought clarification from Glenmark over its alleged “false claims” about the use of FabiFlu on COVID-19 patients with comorbidities and also over the “pricing” of the drug, after receiving a complaint from a Member of Parliament.
“Compared to other therapies approved for emergency use in COVID-19, FabiFlu is much more economical and an effective treatment option…,” Glenmark said in a filing to BSE. The price of the drug is much lower when compared to other countries where it is approved, it added. While the price of the drug by the company is Rs 75 per tablet, in Russia it is Rs 600 per tablet; Japan ( Rs 378), Bangladesh (Rs 350 ) and China (Rs 215 per tablet), Glenmark claimed.
The company has already reduced the price of FabiFlu from Rs 103 per tablet to Rs 75 per tablet. The price reduction was made possible through its efforts to obtain better yield and better scale, and with both API and formulations manufactured at the company’s own facilities in India, the letter to the Drugs Controller General of India (DCGI) V G Somanisaid.
The company also denied making any false claims that Favipiravir is effective in COVID-19 patients with comorbidities like diabetes, hypertension as Phase 3 clinical trial was designed to evaluate the efficacy in these comorbidities.
It pointed out that, “none of the product promotional literature, Summary of Product Characteristics (SmPC) or Product Information leaflet makes any such claim that Favipiravir can be used in mild to moderate COVID-19 patients with co-morbid conditions such as diabetes and heart disease”.
The reference to comorbidity was based on data from Japanese registry the largest collection of real-world evidence on clinical use of Favipiravir in COVID-19, it added. The company also denied having made any such claim at any point in time that Favipiravir alone is effective in treatment of COVID-19 patients with mild to moderate disease, it said.
Glenmark’s FabiFlu is a generic version of Avigan of Japan’s Fujifilm Toyama Chemical Co Ltd, a subsidiary of Fujifilm Corporation. Shares of Glenmark Pharmaceuticals were trading at Rs 414.70 per scrip on BSE, down 0.98 per cent from its previous close.