New Delhi: In a strong rebuttal to the drug regulator, Glenmark Pharma said it has been at the receiving end of careless, unsubstantiated allegations that are devoid of merits related to Covid drug, Fabiflu.
In a reply to V.G. Somani, Directorate General of Health Services, Central Drugs Standard Control Organisation, Glenmark has responded to allegations made in the representation by an unnamed Member of Parliament.
Glenmark said it is "dismayed" by the allegations as it brought an oral anti-viral agent in less than 3 months, being the first and only company to conduct a robust 150-patient randomized controlled trial and launching the drug at a affordable price.
"Glenmark has been at the receiving end of such careless, unsubstantiated allegations that are devoid of merits whatsoever as amply demonstrated above", it said.
On the concern raised by the MP on unaffordability due to high price, Glenmark said Compared to other therapies approved for emergency use in COVID-19, FabiFlu is much more economical and an effective treatment option.
Further, given that Favipiravir is an oral therapy, patients can be treated on an out-patient basis without incurring additional hospitalization expenses, unlike other approved drugs which are injectable and hence require administration at hospitals.
Favipiravir in India when launched was at the lowest market cost (Rs 103/tab) as compared to the cost of Favipiravir in other countries where it was approved.
Despite investing significantly throughout the process of manufacturing, Glenmark has managed to keep the pricing of Favipiravir lower as compared to price of Favipiravir in other countries.
Subsequently on July 13, Glenmark reduced price of FabiFlu to Rs 75 per tablet. The price reduction was made possible through our efforts to obtain better yield and better scale, and with both API and formulations manufactured at Glenmark's own facilities in India.
Today, Favipiravir is a part of several state government protocols and thousands of COVID-19 patients have benefited from the prescription of the product, the company said.
There is an alllegation of misleading/false claim 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 co-morbidities.
In its response, Glenmark said the alleged statement pertaining to co-morbidity in the press release dated June 20 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 in COVID-19.
"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," it said.
"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 said.
There is also an allegation that Favipiravir is not tested as monotherapy in Phase 3 clinical trial in India. "At the outset, Glenmark denies 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.
In the light of the pandemic, in all COVID-19 trials being proposed/conducted across India, all patients receive standard supportive care as per the guidance of Health Ministry as giving the patients placebo alone in such a situation would be unethical as it would deprive the patients of any care at all.
Globally, similar approach, including standard supportive care is adopted in clinical trials that are being conducted to consider treatment options for COVID-19 patients.
Similarly, in the Glenmark Study, as per the guidelines issued by ICMR and Health Ministry, 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," Glenmark rebutted.