FDA approval for Gilead Sciences pill to treat HIV: Report

on Tuesday, 28 August 2012. Posted in News, Products and Guidelines Written By: HealthTzars News Group

FDA approval for Gilead Sciences pill to treat HIV: Report

The FDA has recently approved a four-drug combination pill marketed by Gilead sciences Inc to treat HIV. Sources from FDA said that the combination pill which was formerly called ‘quad’ will be sold under the brand name, ‘Stribid’. 

The shares of Gilead Inc have remained unchanged form their closing figure of 57.19 dollars in Nasdaq since it has focused on development of the new drug which is still in the experimental stages to treat hepatitis –C. This treatment has been acquired by Gilead Inc by the purchase of Pharmasset valued at 11 billion dollars.

Micheal Yee, analyst at RBC Capital Markets said that with the approval for sale of Stribid' by FDA, its sales could earn almost 46 million dollars for Gilead Inc in the current year and estimated revenues of the company to reach approximately 370 million dollars in the next year. Yee said that Gilead is expected to market Stribild aggressively while de-emphasizing two other therapies namely, Atripla and Complera combination therapies.

The company is predicted to have better profit margins with Stribild since it would be wholly owned by Gilead. Stribild contains two HIV medicines which are already approved apart from two new drugs. The older medicines namely, Emtricitabine and Tenofovir are currently sold by Gilead in its combination pill, 'Truvada'. These drugs are also part of a three-drug combination called, 'Atripla'.

The new drugs in Stribild are Elvitegravir and Cobicistat. Continuous research and drug development has evolved treatment for HIV from multi-pill to single-pill regimes. New drug-combination treatments like stribild have helped in simplifying treatment regimes for HIV.

Gilead Inc will have to conduct more studies on Stribild in order to characterize issues like safety of the drug in women and children, resistance development against the new drug and interactions of Stribild with other drugs.

FDA specified that the label of Stribild should warn patients regarding possibility of lactic acid build-up in the blood and severe liver problems by using stribild, both of which can cause fatality. It said hat the label should also specify that the drug can not be used to treat chronic Hepatitis-B viral infection. 

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