American pharmaceutical giant Pfizer on Friday said it cannot speculate on timelines for the India launch of its anti-Covid pill Paxlovid.
In an email response to News18.com, the company said that while it is “thrilled” with the positive results of efficacy of its investigative antiviral drug, the company plans to submit the data for emergency use approval in the US as soon as possible, followed by submissions in other markets. It, however, refused to speculate on regulatory timelines.
Pfizer, last week, announced its investigational antiviral, PF-07321332, for the treatment of Covid-19 in high-risk adult patients after it showed high efficacy. During its Phase 2 and 3 study, the company found that when co-administered with a low dose of ritonavir, it reduced the risk of hospitalisation and death by 89% amongst non-hospitalised, high-risk adults with Covid-19 as compared to those who were given a placebo.
“Based on these positive results and our conversations with both the FDA and an independent data monitoring committee, we plan to submit the data for EUA (emergency use authorisation) in the US as soon as possible,” the company spokesperson said. “It will be followed by submissions in other markets. However, we cannot speculate on the regulatory timelines.”
“Manufacturing facilities for PF-07321332 include Ireland, Germany and Italy following full GMP procedures. Pfizer’s goal is to deliver safe and effective oral anti-viral therapeutic(s) as soon as possible and at an affordable price, subject to regulatory authorization, across the globe,” the spokesperson added.
Another anti-Covid pill by Merck, Molnupiravir, is expected to reach the Indian market soon. Merck has entered into voluntary licensing agreements with at least eight Indian drug makers, including Cipla, Dr Reddy’s Laboratories, Sun Pharma, Hetero, Aurobindo Pharma, and others, for the oral medication. Some of these drug makers have finished conducting the late-stage clinical trials and have submitted the data to the country’s apex drug regulator for a marketing nod.
“With data on over 700 patients submitted, the emergency-use approval to American pharmaceutical giant Merck’s anti-Covid pill Molnupiravir is likely to be given soon,” chief of the Covid Strategy Group Dr Ram Vishwakarma at the Council of Scientific and Industrial Research (CSIR) told News18.com on Thursday.
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