Hetero seeks Emergency Use Authorization for Molnupiravir in India
The use of Molnupiravir, an experimental oral drug having antiviral properties, has resulted in early recovery of COVID-19 patients with mild symptoms when compared to standard treatment during Phase III clinical trials, Hetero said on Friday citing interim data. The Hyderabad-based drugmaker also said it has approached the Drug Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for Molnupiravir in India.
It has conducted Phase III trial on mild COVID-19 patients
Hetero had commenced a Phase III, comparative, randomized, multicenter clinical trial on mild COVID-19 patients. These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care (test arm) versus standard of care alone (control arm) in mild COVID-19 patients with a positive SARS-CoV-2 RT-PCR test for COVID-19 and randomized within five days of onset of symptoms.
Here is how the trial was conducted
The experiment was conducted in two methods. The Times of India reported that patients in the trial were randomized to receive either the Molnupiravur capsules 800mg (4*200 mg) every 12 hours twice daily for five days, along with the standard case as per the Indian Council of Medical Research (ICMR), guidelines or to receive standard of care alone in the control arm.
Hetero had an agreement with MSD for Molnupiravir's manufacturing, supply
There were fewer hospital admissions in the Molnupiravir group compared to the standard of care alone over 14 days of observation, the interim results said. Notably, in April this year, Hetero had entered into a non-exclusive licensing agreement with MSD (trade name for the US-based Merck & Co., Inc.) to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs).
What Hetero said regarding the Phase III trial
"Phase III trial demonstrates statistically significant fewer hospital admissions, faster time to clinical improvement and early negative SARS-CoV-2 RT-PCR with Molnupiravir treatment in mild COVID-19 patients compared to standard of care alone," Hetero said.
Hetero is conducting a separate study on moderate COVID-19 patients
"There was no mortality in either (Phase III) group and all adverse events were non-serious, mild in severity, and none led to drug discontinuation," Hetero said. The most common adverse events reported were nausea, diarrhea, and headache which were resolved completely, according to Hetero, which is also undertaking a separate Molnupiravir study on moderate COVID-19 patients approved by Central Drugs Standard Control Organization (CDSCO).
