The US Food and Drug Administration's (FDA) drug regulatory division announced the approval of a new indication for Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate), making it the first drug with an approved indication to prevent the transmission of the Human Immunodeficiency Virus (HIV).
The drug was first approved in August 2004 under priority review for the treatment of existing HIV. FDA said under the new indication, approved 16 July 2012 via a supplemental New Drug Application (sNDA), the drug will be one part in a "comprehensive strategy" to combat the virus responsible for AIDS.
FDA said the approval amounted to a "significant regulatory development."
"Today's approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret Hamburg. "Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
Truvada belongs to a class of drugs known as Pre-exposure Prophylactics (PrEP), which are used before exposure to a virus and can lower a person's chances of contracting the virus for which it is indicated.
Product Paired With REMS Plan, Black Box Warning
FDA was quick to note the drug is not intended to be used as a stand-alone treatment for the prevention of HIV, but is instead intended to be used in conjunction with safe sex practices such as condoms.
Even then, the drug is not without risk. The agency said the drug can only lower-not eliminate-the risk of contracting HIV. There are also "manageable and monitor-able" side-effects such as kidney damage and a reduction in bone density, FDA's Debra Birnkrant, Director of CDER's Division of Antiviral Products, said.
The drug will be paired with a Risk Evaluation and Mitigation Strategies (REMS) program focused on prescriber training and education, as well as a Black Box warning-FDA's strongest to consumers. Additionally, health care professionals will be required to test patients for HIV every three months prior to prescribing. FDA said it "strongly recommends against" prescribing Truvada to patients with an unknown HIV status.
It will also be important for consumers to stick with the recommended dosing regimen, FDA said.
Controversy Surrounding Approval
The drug's approval also came in the face of some intensive criticism from outside groups, including the AIDS Healthcare Foundation, which called for Hamburg's resignation in March 2012 in light of what it referred to as FDA's "gross mismanagement of new product reviews and a lack of transparency."
The group said it was upset that Truvada received expedited review status at the agency despite not deserving it.
"Under the FDA Manual of Policies and Procedures, an expedited review is granted only if a drug meets certain criteria; it must have the potential to be a "[s]afe and effective therapy where no satisfactory alternative therapy exists," or "[a] significant improvement compared to marketed products, including nondrug products or therapies," said AHF. "Truvada as PrEP does not meet this criteria."
While FDA did not address AHF's comment during a 16 July press call announcing Truvada's approval, it did address some of the drug's other safety concerns. Some safety advocates were concerned the drug could actually result in riskier behavior if consumers thought the product was a means to prevent HIV by itself. For Birnkrant, the data showed otherwise. "What we found that was condom use actually increased over time" when people were using Truvada, Birnkrant said.
FDA's approval of Truvada marks the second significant approval of an HIV-related medical product in as many weeks. On 3 July 2012 the agency approved OraSure's OraQuick home testing kit for the detection of HIV-the first such device to be approved by the agency.