Compared to Tamiflu that requires two doses daily for 5 days, now a single dose of Xofluza can cure the illness. New drug to reach Indian market in 2-3 years.
New Delhi: Bouts of influenza or the flu that causes headaches, runny nose, cough and muscle pain may now be cured in just one day — and with just one pill.
The US drug regulator — Food and Drug Administration (US FDA) — has approved a new drug, Xofluza, which works differently from other flu drugs. Compared to Tamiflu, which requires two doses daily for a five-day course, a single dose of Xofluza can cure the illness in just one day.
Xofluza has been found to reduce symptoms and duration of the flu — a contagious respiratory illness caused by influenza viruses — if the patient is treated within 48 hours of becoming sick.
The earlier studies conducted by its Japanese parent firm has suggested that Xofluza (baloxavir marboxil) stopped an infected person from passing the virus to others within 24 hours against the other treatments that took 72 hours.
On 24 October, the USFDA approved Xofluza, made by Japanese pharmaceutical company Shionogi for the treatment of acute uncomplicated influenza. The drug has been approved for patients who are of or above 12 years of age.
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA commissioner Scott Gottlieb said in the press statement.
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Why taking the entire dose is important
The flu infection, otherwise, is self-limiting with severe illness lasting for three to four days. Most people recover within a week after consuming non-prescription medicines such as Tamilflu, D’Cold Total and Cheston Cold.
Sometimes, not finishing the entire course of the medication could help certain viruses to become drug resistant, which may create a life-threatening flu infection or aggravate existing illnesses.
Seasonal flu kills up to 6.5 lakh people every year, according to the World Health Organization, with most deaths occurring from pneumonia, heart or brain inflammation and circulatory shock from organs not getting enough blood or oxygen.
In the new drug, there are no chances of missing any dose and hence, it can prove more effective with lesser side effects.
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New drug likely to arrive in India in 2-3 years
After the USFDA approval, Indian manufacturers will file applications with the Central Drugs Standard Control Organisation to take permissions for the manufacture of the formulation of drug ‘baloxavir marboxil’.
“CDSCO will then order the clinical trial of drugs at four different geographies on at least 100 patients. The launch of drug will take at least two to three years in India,” said Ashok Kumar Madan, executive director of Indian Drug Manufacturer Association.
Doctors in India, however, refused to comment on the approval of the drug as they are awaiting the nod from CDSCO after the clinical trials on local patients.