The deadly Hepatitis C virus afflicts as many as 150 million people worldwide and possibly 12 million in India.
A latest breakthrough treatment for the deadly Hepatitis C virus could
soon be available in India as 11 Indian firms have been given licenses
by its American manufacturer following an approval from US authorities.
The drug called Epclusa which is developed to treat all genotypes of the
Hepatitis C virus by Gilead Sciences in its latest breakthrough
treatment was last week approved by the US Food and Drug Administration
(FDA).
The deadly Hepatitis C virus afflicts as many as 150 million people worldwide and possibly 12 million in India.
This pan-genotypic treatment does not require gene-type testing,
eliminating the need for costly gene--type diagnostics, allowing doctors
and specialists to prescribe the medicine to anyone who tests positive
for Hepatitis C, by taking one pill a day for 8-12 weeks they are cured.
“The approval of Epclusa represents an important step forward in the
global effort to control and potentially eliminate HCV as it provides a
safe, simple and effective cure for the majority of HCV-infected
patients, regardless of genotype,” said Ira Jacobson, MD, chairman of
the Department of Medicine at Mount Sinai Beth Israel, New York and a
principal investigator in the Epclusa clinical trials.
“Building on the established backbone of sofosbuvir, Epclusa
demonstrated consistently high cure rates across all genotypes,
including among patients with genotype 2 and 3, who traditionally have
required ribavirin or other multi-pill regimens,” he said.
As part of its effort to make it an affordable treatment, Gilead
Sciences, together with its 11 partners in India, are pioneering a
Voluntary Licensing model that transfers technology and Intellectual
Property for latest treatments and cures for viral Hepatitis and HIV.
Gilead, in 2014, licensed its newly-approved HCV regimens to 11 of
India’s pharmaceutical companies, including the prospective Epclusa,
which had not yet been cleared by the US FDA.
“This forward thinking strategy opened for these Indian companies the
market across all of India for generic versions of these drugs, plus the
market for 100 other countries,” an industry source said.
Because of India’s capabilities in generic manufacturing, where quality
and low cost co-exist hand in hand, Gilead Sciences recognised that to
expand patient access and to deploy these life-saving cures to low
income countries around the world to the patients who need treatment
most.
It would be mutually beneficial to license the Intellectual Property for
its new HCV medicines to companies in India which had already
established supply chain linkages with countries across Africa, Asia,
Eastern Europe, Mongolia, and other hard to penetrate markets, industry
sources said.
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