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New HIV Drug Gains Priority Status By FDA

HIV Drug FDA Approval

A new HIV drug gained priority review status this week by regulators in the United States.

The United States Food and Drug Administration said Friday that it has given priority review status to the experimental drug dolutegravir, used in the treatment of HIV. This type of status is issued for drugs that show signs of significant improvement above treatments already in use.

A report by Reuters writes that dolutegravir is from an experimental class of drugs considered to be integrase inhibitors. The new HIV drug, taken once daily, would be used to block the virus which causes AIDS from entering cells.

The new HIV drug is from Britain’s GlaxoSmithKline, the country’s largest drug manufacturer. The company is the largest shareholder of ViiV Healthcare, a collaborative effort between GlaxoSmithKline and Pfizer. Viiv Healthcare originated in 2009 after the drug manufacturers agreed to combine their HIV and AIDS treatment efforts.

According to an article in Medical News Daily, GlaxoSmithKline’s dolutegravir inhibitor stands to generate significant profits if approval is given by the Food and Drug Administration. Manufacturing analysts have reportedly speculated that the new HIV drug could reach billions of dollars in sales annually.

Human immunodeficiency virus, or HIV, is a type of retrovirus that can lead to the development of AIDS. Considered an infectious disease, acquired immunodeficiency syndrome causes failure of the immune system. People infected with the disease are susceptible to life-threatening illnesses.

The new HIV drug is scheduled to receive its verdict on approval by the United States Food and Drug Administration on August 17, 2013.

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