FDA Rejects 2 HIV Drug Treatments from Gilead Sciences
Apr 29, 2013 12:52 PM EDT
Gilead Sciences Inc said Monday that the United States Food and Drug Administration shot down two new HIV drugs as standalone therapies, according to Reuters.
The FDA said insufficient documents and inadequate validation for specific tests were the reasons the HIV drugs were not approved.
Gilead is looking to get permission from the agency for its drug, elvitegravir. The drug will be one of many treatments that fight HIV, or Human Immunodeficiency Virus. The drug is used to battle the enzyme integrase which allows viruses like HIV to multiply in the body.
The second drug Gilead is seeking approval for is cobicistat. Unlike elvitegravir, this drug does not directly fight HIV, but provides strength for other HIV medicines that fight the virus.
Currently, both drugs are embedded in the Gilead-made tablet Stribild. Stribild is an HIV-treatment tablet taken once a day which includes four different medications. The FDA approved the drug in August 2012.
According to data from Thomson Reueters, it's expected for elvitegravir to bring in revenue from sales in the amount of $300 million by 2016, if the drug is approved. Sales revenue for cobistat should be around $242 million in the next four years.
In 2012 Gilead’s array of antiviral drugs brought sales revenue of approximately $8.14 billion.
According to the Centers for Disease Control and Prevention, HIV is “virus that can lead to acquired immunodeficiency syndrome, or AIDS. Unlike some other viruses, the human body cannot get rid of HIV. That means that once you have HIV, you have it for life.”
Currently there is no cure for HIV or AIDS. However, with adequate treatment HIV can be handled. Approximately 50,000 individuals are infected with HIV each year. In 2009 a little over 1.1 million people were living with the disease.
Doctors are still working to find a cure.
Gilead Sciences is working with the FDA to rectify the current issues and get the drugs approved.