New Delhi: Drug firm Strides Shasun said it has received pre-qualification from the World Health Organization (WHO) for its rectal artesunate product for the pre-referral management of severe malaria.
The pre-qualification from the WHO for the 100mg rectal artesunate suppositories (RAS) has been achieved with support from Medicines for Malaria Venture (MMV) and funding from Unitaid, Strides Shasun said in a filing to BSE.
This pre-qualification enables countries to procure life-saving RAS with donor funding, thus ensuring increased access to this potentially life-saving intervention, it added.
Severe malaria can kill within 24 hours if left untreated, and travel times to hospital can be long, particularly for children from remote rural communities, Strides Shasun said.
“We are honoured to have collaborated with MMV and Unitaid on this project and to have now received WHO approval for our novel-delivery soft-gel artesunate suppositories for use in children suffering from severe malaria,” Strides Shasun Group CEO and MD Arun Kumar said.
The company will now leverage its significant presence in Africa to register and distribute the product where needed on the continent. To this end, dossiers have already been submitted in 25 of the countries that could benefit most, he added.
On the development, MMV CEO David Reddy said, “This second approval of a RAS product from the WHO pre-qualification programme will further expand access to this important life-saving intervention and help save more young lives from malaria.”