FABIFLU CHEAPEST TO TREAT COVID: GLENMARK
Writes to DCGI, says claims over pricing of the drug false
Glenmark on Tuesday said Fabiflu — its generic version of oral antiviral drug favipiravir — is cheaper than other drugs, including remdesivir, tocilizumab, itolizumab, etc, approved for emergency use for the treatment of Covid-19.
The Mumbai-based firm was responding to the Drugs Controller General of India’s (DCGI) letter seeking clarification over its alleged ‘false claims’ on Fabiflu’s efficacy on Covid-19 patients with comorbidities and high price of the drug, after a legislator raised these issues in a letter to Health Minister Harsh Vardhan.
Glenmark said these were “careless, unsubstantiated allegations devoid of merits”.
On Tuesday, Glenmark’s shares ended the day’s trade at ~414 apiece, down 1 per cent.
The company said it has developed the active pharmaceutical ingredient in-house for Fabiflu, and till date remains the only company in India to have conducted a randomised controlled clinical trial for favipiravir.
The company claimed that favipiravir was launched at the lowest market cost (~103 per tablet) in India as compared to its cost in other countries like Russia, Japan, Bangladesh and China.
“Despite investing significantly throughout the process of manufacturing, Glenmark has managed to keep the pricing of favipiravir lower in India than other countries,” Glenmark said.
The company also claimed that since favipiravir is an oral therapy, patients can be treated on an out-patient basis without incurring additional hospitalisation expenses.
In his letter to the health minister (dated June 26), Member of Parliament (MP) Dr Amol Kolhe had said since a patient has to take these tablets for 14 days (or 122 tablets), at a price of ~103 per tablet, this would bring the total cost of treatment to ~12,500. He had said “the Government of India should ensure affordability of the drug to the common people.” On July 13, Glenmark had reduced the price of the drug to ~75 a tablet, bringing the cost of treatment down to ~9,150.
The DCGI had asked Glenmark to clarify if it has claimed that the drug is effective on patients with comorbidities such as hypertension or diabetes, whereas in reality, according to protocol summary, the trial was not designed to assess Fabiflu in comorbid conditions.
Kolhe had claimed that Fabiflu has not been tested as monotherapy. It was given along with Icmr-approved standard protocol treatment in selective clinically stable Covid patients.
Kolhe alleged that the data “clearly shows” that the claims made by Glenmark in their press conference that Fabiflu alone is effective on mild to moderate patients are “completely misguided” to all clinical practitioners and the people of India.
Glenmark denied having made any such claim. It said it would be “unethical” to deny patients of any care and put them only on placebo. “In the light of the pandemic, in all Covid19 trials being proposed/conducted across India, all patients receive standard supportive care as per the guidance of the health ministry,” it clarified.
However, standard supportive care in Glenmark’s Favipiravir studies did not include hydroxychloroquine or any other antiviral 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,” it said. “All approvals to Glenmark were granted in accordance with the extant law and with stringent conditions,” it claimed.
Also, clarifying if Glenmark made any “false or misleading claim” that Favipiravir is effective on patients with comorbidities, it said the alleged statement pertaining to co-morbidity in the press release dated 20 June 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 Japanese registry — the largest collection of real-world evidence on clinical use of Favipiravir on Covid-19 patients,” the firm said.