Mumbai firm Glenmark Pharmaceuticals on Tuesday defended its pricing of favipiravir, an oral antiviral drug for coronavirus patients, and said that compared to other therapies approved for emergency use in Covid-19, the FabiFlu tablet was “much more economical and an effective treatment option”.
This came after the Drug Controller General of India had reportedly sent the company a notice on overpricing and allegations regarding Glenmark’s claims of effectiveness of the drug in co-morbid conditions such as hypertension and diabetes. The concerns were raised by a member of Parliament, and were sent to the company by the drug regulator in a letter dated July 17, according to ANI.
The company, however, claimed that its statement pertaining to co-morbidity was not derived from Glenmark’s ongoing late-stage trial of favipiravir, but was based on data from Japanese clinical studies. It added that none of the company’s product information for FabiFlu make any such claims.
“In fact what is surprising is that the allegation of false claim is being made that when Glenmark, being a responsible corporate citizen, explicitly referenced upfront the Japanese registry, and at no point linked it to our India Phase 3 clinical trial,” the company added in its statement. “In view of the above, it is clear that Glenmark’s communication at the launch of the said product has been completely misread and/or quoted out of context which is harming our reputation.”
Glenmark claimed that FabiFlu’s price in India when launched was at the lowest market cost – Rs 103 per tablet – compared to the cost of Favipiravir in other countries where it was approved. Its price of 75 rupees or $1 per tablet compares to Rs 600 per tablet in Russia, and between Rs 200 and Rs 380 per tablet in China, Bangladesh and Japan, the company said.
The company also denied making any claims that “favipiravir alone” is effective in treatment of mild-to-moderate Covid-19 patients. “It is further important to note that the protocol of Glenmark Study was duly approved by SEC [Subject Expert Committee] after subjecting the draft protocol to much interrogatories and challenge,” it added.
Therefore, the concerns raised by the Member of Parliament that Fabiflu was not tested as a monotherapy in any of the mild to moderate patient in Glenmark study “is wholly misplaced and devoid of understandings of the clinical trial principles in a pandemic situation”, the company said. “...Glenmark has been at the receiving end of such careless, unsubstantiated allegations that are devoid of merits whatsoever as amply demonstrated above.”
On July 13, Glenmark had reduced the price of favipiravir by 27% from Rs 103 per tablet to Rs 75. “The price reduction has been made possible through benefits gained from higher yields and better scale,” the company had said in a press release
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