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The Covid-linked DARE-19 trial is poised to come to India. The trial evaluates AstraZeneca’s diabetes drug Dapagliflozin (Forxiga) on Covid-19 patients who risk developing serious complications like organ failure.
The trial’s key sponsor Saint Luke’s Mid America Heart Institute and collaborator AstraZeneca are expected to approach the Drug Controller General of India in the coming weeks. The hope is to get approvals to start the trial by later this month, people familiar with the trial told BusinessLine .
The DARE-19 study evaluates if Dapagliflozin reduces the risk of disease progression and worsened organ dysfunction in patients hospitalised with Covid-19 who also have cardiovascular, metabolic or kidney risk factors and are at risk of developing serious complications, said Anil Kukreja, Vice-President (Medical Affairs & Regulatory), AstraZeneca Pharma India.
This is an external scientific research led by Principle Investigator Mikhail Kosrobod from Saint Luke Mid America Heart Institute. And they have got in touch with investigators in India to approach the regulatory authorities and start the study in India as well, said Kukreja.
Late in April, AstraZeneca and Saint Luke’s Institute said they had initiated the DARE-19 study, or global Phase III trials on Dapagliflozin to assess its potential in hospitalised Covid patients.
India plan
On the India-plan, Vijay Chopra, national coordinating investigator for DARE-19 in India, told BusinessLine , about 10 sites have been identified and submissions are being made to the DCGI. The trial is expected to start later this month and finish in September, he said. Chopra, a Senior Director at Max Super Speciality Hospital (Delhi), was appointed at the helm of the Dare study in India by Saint Luke’s Institute.
This development comes even as AstraZeneca leads the race for a Covid vaccine through its partnership with Oxford University. Their partnership to develop and commercialise a Covid-vaccine candidate has made much headway, and Governments in the UK, the US and Brazil, for instance, have inked deals for the prospective vaccine.
Pointing to the multiple agreements across the globe, Gagandeep Singh, Managing Director with AZ Pharma (India), said, the effort was to provide equitable access to the product across the globe.
Even as the DARE-19 trial is in the offing, Dapagliflozin achieved another regulatory milestone in India as it received the DCGI’s approval to be marketed to patients with heart failure with reduced ejection fraction (HFrEF).
Singh pointed out that heart failure affects over 6 crore people worldwide and at least 8–10 million in India. The drug is priced at ₹57 per tablet and taken once a day.
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