Glenmark has sent a letter responding to the DCGI which had recently sought a clarification from the company about “false claims” about use of anti-viral FabiFlu on COVID-19 patients with comorbidities and “pricing” of the drug, after receiving a complaint from a Member of Parliament. The regulator had asked the company for clarifications stating that “cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle-class people of India.” (Click here to read)
Addressing the regulator’s concerns about pricing, the company’s letter states, “Compared to other therapies approved for emergency use in COVID-19, FabiFlu is much more economical and an effective treatment option.” Drawing comparisons between FabiFlu and the other drugs being used for COVID-19 treatment, the company says that the estimated total cost of therapy for the full course of Favipiravir is Rs 9150 but the estimated cost of therapy of Remdesivir, Tocilizumab and Itolizumab comes to Rs 24,000 – 30,000; Rs 44,000 and Rs 32,000 respectively.
The letter informs that Favipiravir in India when launched, was at the lowest market cost (Rs 103/200 mg tab) as compared to the cost of Favipiravir in other countries where it was approved. Citing trade data from several countries, the letter says that the company has managed to keep the pricing of favipiravir lower as compared to the drug’s price in other countries such as Russia (Rs 600/tab); Japan (Rs 378/tab); Bangladesh Rs 350/tab); China (Rs 215/ tab). It also states that the company has worked to reduce the price of FabiFlu and cut it to Rs 75/- per tablet.
“Further, given that Favipiravir is an oral therapy, patients can be treated on an out-patient basis without incurring additional hospitalisation expenses, unlike other approved drugs which are injectable and hence require administration at hospitals,” justifies the company.
The company’s letter also addresses allegations about misleading/false claim that Favipiravir is effective in COVID-19 patients with comorbidities like diabetes, hypertension through the letter. It clarifies, “The alleged statement pertaining to co-morbidity in the press release dated 20 June 2020 was not derived from or alluded to Glenmark’s ongoing Phase 3 clinical trial. On the contrary, the reference to comorbidity was clearly based on data from the Japanese registry – the largest collection of real-world evidence on the clinical use of Favipiravir in COVID-19.”
“Our bonafide are further corroborated by the fact 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,” states the letter.
Glenmark, in its letter, also denies making claims that “Favipiravir alone” is effective in the treatment of COVID-19 patients with mild to moderate disease
It states, “In the Glenmark Study, as per the guidelines issued by ICMR/ MoH&FW, patients with mild to moderate COVID 19 symptoms were treated with Favipiravir plus recommended standard supportive care versus standard supportive care alone. It is pertinent to note that the standard supportive care in Glenmark Study did not include HCQ or any other anti-viral drug. Consequently, since both arms of the Glenmark Study received standard supportive care under this design, any advantage observed in the treatment arm can solely be attributed to the administration of Favipiravir.”
The letter also states that Glenmark has been at the receiving end of “careless, unsubstantiated allegations that are devoid of merits”.
The regulator’s response to Glenmark’s clarifications is awaited.