WASHINGTON – FDA officials in their latest series of drug approvals gave a clean-chit to the newly developed Hepatitis C pill that will reshape the future of live-destroying virus treatment by curing all the primary forms of Hepatitis C.
This drug is prepared by Gilead Sciences and is a combination pill named Epclusa for patients suffering from the acute liver-damaging virus. Food and Drug Administration department finally gave approval to this new medicine this Tuesday. Approval of this drug is expected to make the functioning of recently approved five other hepatitis drugs easier. These five drugs approved earlier could cure different stages of liver infection.
Gilead Sciences have scraped billions previously by replacing older hepatitis drugs with two new versions of Hepatitis C medicine. However, company’s aggressive pricing is being contempt by several patient groups, insurers and political leaders globally.
Hepatitis C Drug Pricing
As per current pricing, every Epclusa pill comes with a price tag of $890 and the entire 12-week course of treatment would cost a patient $74,760. Gilead’s previous drugs Harvoni initially priced $1,125 per pill while its first Hepatitis C pill, Sovaldi costs approximately $1,000 per pill. The excessively priced drug also led to a national debate over escalating medicine cost.
However, since 2014 FDA has also initiated approval of drugs from other manufacturers including AbbVie Inc., Merck & Co., and Bristol-Myers Squibb Co. leading to cost control.
Epclusa is a combination of Sovaldi and a new drug that uses different mechanisms to fight Hepatitis C virus.
According to the clinical trial data reviewed by the FDA, Gilead’s new drug can treat all six genetic subtypes of Hepatitis C virus and is effective in 95% of the cases. This pill is formulated to be used as a combination with ribavirin (an antiviral medicine).
As per FDA, there are few side-effects of using the drug which involves a headache and fatigue.
Despite being recommended by medical societies as first-line treatments for hepatitis C patients, only 3% of the Medicaid beneficiaries are eligible for the treatment due to the cost involved (as of 2014). Medicaid is a federal government and state-run health program for the low-income group.
Approval of Epclusa led to a hike of 5.2% in Gilead Sciences Inc. shares on Tuesday.
As per Centers for Disease Control and Prevention, approximately 2.7 million US residents are affected by Hepatitis C virus resulting in over 19,000 deaths in 2014.
