The World Health Organization has approved a drug made in Kikuyu for treatment of Covid-19. It is ready for production.
WHO said, however, this is a new medicine with little available safety data.
“WHO recommends active monitoring for drug safety, along with other strategies to mitigate potential harm,” the organisation said in a statement.
The drug was invented at US’s Emory University and is owned by Merck & Co. Merck has allowed Kikuyu’s Universal Corporation Limited, and 26 other companies around the world, to make generics for poor countries.
The World Health Organization said although the drug is approved, the 27 companies must submit samples of what they have made for quality checks.
WHO said because of safety data gaps, molnupiravir should be provided only to non-severe Covid-19 patients with the highest risk of hospitalisation.
“These are typically people who have not received a Covid-19 vaccination, older people, people with immunodeficiencies and people living with chronic diseases,” it said in a statement.
“Children and pregnant and breastfeeding women should not be given the drug. People who take molnupiravir should have a contraceptive plan, and health systems should ensure access to pregnancy testing and contraceptives at the point of care.”
Universal, which is owned by Strides Pharma Science Limited of India, confirmed they are ready to produce the drug in Kenya.
“We are pleased to partner with MPP for providing global accessibility of the generic molnupiravir both from India and Kenya,” Dr R. Ananthanarayanan, head of Strides, said in a statement.
The Medicines Patent Pool (MPP), is a UN-backed body that brokered the deal between Merck and the 27 manufacturers in poor countries.
Molnupiravir, an oral tablet, is given as four tablets (total 800 mg) twice daily for five days, within five days of symptom onset. Used as early as possible after infection, it can help prevent hospitalisation.
The WHO said its recommendation is based on new data from six randomised controlled trials involving 4,796 patients around the world. This is the largest dataset on this drug so far.
WHO said although molnupiravir is not widely available, the voluntary licensing agreement with 27 makers will improve supply.
Molnupiravir is an antiviral that was originally developed to treat the flu, caused by another coronavirus.
It works by stopping coronavirus from growing and spreading and is taken as early as possible after infection, to prevent more severe symptoms from developing.
MPP said five companies will focus on producing the raw ingredients, 13 will produce both raw ingredients and the finished drug and nine companies – including Universal Ltd – will produce the finished drug.
Founded in 2010, the Geneva-based Medicines Patent Pool negotiates with patent holders to allow the manufacture of generics in poor countries.
(Edited by V. Graham)
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