Two Indian drugmakers have asked permission to finish their late-stage trials on Merck & Co’s experimental antiviral drug molnupiravir in average COVID-19 sufferers.
The 2 Indian drugmakers, Aurobindo Pharma Ltd and MSN Laboratories plan to proceed late-stage trails of the drug for the ones with gentle COVID-19, the Indian drug regulator’s knowledgeable committee mentioned on Friday. The 2 corporations one by one sought permission to finish trials in relation to average COVID-19 sufferers after having submitted period in-between medical trial information across the effectiveness of the drug in treating this class of sufferers, the committee disclosed, throwing into query the efficacy of the experimental drug in bettering results for sufferers with average instances of COVID-19.
One at a time, a senior supply at India’s drug regulator informed Reuters that molnupiravir had proven no “vital efficacy” against moderate COVID-19 cases.
Shares in Merck soared last week after it and partner Ridgeback Biotherapeutics said an interim analysis of a late-stage clinical trial on molnupiravir showed the medicine nearly halved the risk of hospitalisation or death for patients with mild or moderate COVID-19.
It was not immediately clear whether the Indian drugmakers and Merck used identical criteria to define moderate COVID-19 cases.
Aurobindo Pharma, MSN and Merck did not immediately reply to Reuters’ requests for comment.
Merck has entered into voluntary licensing agreements with at least eight Indian drugmakers for molnupiravir, with an aim to turn the South Asian nation into a manufacturing hub for the drug to supply low- and middle-income nations.
Aurobindo has been conducting a clinical trial https://bit.ly/2WYn61G on the drug in 100 patients with moderate COVID-19 since August this year. According to its trial details, moderate patients included those with fever, coughing, breathing difficulties and oxygen deficiency.
Of the eight Indian firms, five – Dr Reddy’s Laboratories, Cipla, Sun Pharma, Torrent Pharmaceuticals and Emcure Pharmaceuticals – are conducting a joint trial for the antiviral drug only in mild COVID-19 patients in an outpatient setting.
The other licenced company, Hetero, in early July announced interim data from its own late-stage trial in treating mild COVID-19 patients and submitted an application for emergency use approval for the same.
Hetero is separately conducting a study on moderate COVID-19 patients and it has said clinical results on the same will be shared in due course.