Treatment drug for Hepatitis C will soon be available in India
Posted on: 10/Jul/2016 12:11:35 PM
Eleven Indian firms have been given licenses by an American manufacturer to make available a breakthrough treatment for the Hepatitis C virus. The licenses were given after receiving approval from authorities in the US.
The drug is called Epclusa. It has been developed to treat all genotypes of the Hepatitis C virus. American manufacturer of the drug, Gilead Sciences, received approval from the US Food and Drug Administration, or FDA, last week.
Approximately 150 million people all over the world and about 12 million people in India are affected by the deadly Hepatitis C virus. The new treatment does not require gene-type testing, eliminating the need for costly gene-type diagnostics, allowing doctors and specialists the ability to prescribe the medicine to anyone who tests positive for Hepatitis C, by taking one pill a day for 8-12 weeks before a cure is achieved.
Speaking about this, a senior executive at the Department of Medicine at Mount Sinai Beth Israel, New York and a principal investigator in the Epclusa clinical trials said, 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. 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.
Gilead Sciences, along with its 11 Indian partners, are pioneering a Voluntary Licensing model that transfers technology and Intellectual Property for latest treatments and cures for viral Hepatitis and HIV. In 2014, Gilead 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.
According to industry sources, 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. 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.
