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WHO launches safety monitoring study for molnupiravir in India, other countries

WHO launches safety monitoring study for molnupiravir in India, other countries

The primary objective of the study is to characterise and estimate the incidence of all adverse events, including serious adverse events, medication errors, off-label use and misuse occurring in enrolled patients.

WHO noted that that due to the urgent need to make therapeutic agents available for treatment of COVID-19, regulatory agencies are using fast-track emergency procedures to expedite the approval process. WHO noted that that due to the urgent need to make therapeutic agents available for treatment of COVID-19, regulatory agencies are using fast-track emergency procedures to expedite the approval process.

The World Health Organization (WHO) has launched a safety monitoring study of recently launched anti-viral drug molnupiravir for treatment of mild to moderate COVID-19 infection in low and middle-income (LMI) countries, including India.

Molnupiravir has been newly introduced in the market as the first oral medicine for treatment of non-severe COVID-19 disease but safety of the anti-viral drug has been a matter of debate.

WHO said that a multicenter, multi-country observational, prospective, single-arm, cohort study for the active safety surveillance of molnupiravir will be conducted in health facilities that provide molnupiravir to patients.

The primary objective of the study is to characterise and estimate the incidence of all adverse events (AEs), including serious adverse events (SAEs), medication errors, off-label use and misuse occurring in enrolled patients.

WHO aims at secondary objectives as well which are to characterise and estimate the incidence of maternal and perinatal outcomes in women inadvertently exposed to molnupiravir during pregnancy and neonate/ infant/ child exposed during breastfeeding.

It wants to detect signals of drug-drug interactions and interactions with traditional medicines to estimate the incidence of severe COVID-19 disease following treatment with molnupiravir and to detect possible lack of adherence to treatment or lack of effect.

"Study enrolment will start when the first authorized dose of molnupiravir is prescribed in the participating study sites. Enrolled patients will be actively followed-up for three months after their last dose. Pregnant women inadvertently exposed to molnupiravir will be followed until the end of the pregnancy and their children will be followed up until the age of 12 months," a WHO document said.

"Participants will be recruited among patients who are prescribed molnupiravir for treatment of non-severe COVID-19 disease at sites participating in this study. Study participation will be strictly voluntary," it said, adding that the target study size is 30,000 patients treated with molnupiravir for COVID-19 disease.

WHO noted that that due to the urgent need to make therapeutic agents available for treatment of COVID-19, regulatory agencies are using fast-track emergency procedures to expedite the approval process, based on limited clinical efficacy and safety data.

Pharmacovigilance has an important role to provide further evidence on the safety of this medicine in the general population and to ensure potential safety issues are detected early and addressed without delay, and any impact on the benefit-risk ratio can be identified and assessed.

To date, India, Europe, UK, and USA have granted emergency use listing for molnupiravir. Despite over a dozen domestic pharmaceutical companies manufacturing the anti-viral drug on affordable prices, the Indian government has been against including it in the treatment protocol over safety issues.

It has also not received the Indian Council of Medical Research's (ICMR) nod for inclusion in India's national COVID-19 treatment protocol, although the drug has received an emergency use authorization (EUA) from the Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO).

Also read:  WHO recommends anti-viral drug molnupiravir for non-severe COVID-19 patients