Gilead Successfully Acquired Approval For Odefsey From FDA

The American biotech giant is struggling to keep its market dominance intact by getting its new drugs approved.

Gilead Sciences has bagged another drug approval from the Food and Drug Administration, on Tuesday, for its novel drug Odefsey – another regimen based on TAF. The proposed drug is expected to treat patients suffering from HIV-1 infection.

This newly introduced drug, Odefsey, is a combination of two of the Gilead’s older drugs: emtricitabine and rilpivrine along with an advanced form of tenofovir known as tenofovir alafenaminde (TAF) while not using the tenofovir disoproxil fumarate, TDF. Only at one-tenth of its dose, the new, improved, and advanced form of tenofovir’s prodrug has shown antiviral efficacy, which is in similar line with the effectiveness of Viread; biotech titan’s aging drug also chemically known as TDF.

The statement forwarded by Gilead about the efficacy of the new drug had the following words: “Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91% less tenofovir in the bloodstream.”

The organization’s new drug is the smallest pill among all the single-tablet regimens that have been used for HIV treatment. The prescription of the drug could be made to patients, aged 12 years or older, with HIV-1 having no history of antiretroviral treatment. For the optimum efficacy of the drug, the HIV-1 RNA level should be equal to or lower than 100,000 copies per mL.

In its press release, the $125 billion organization said, “Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.”  

Currently, the Californian biotech titan is the frontrunner in the HIV market having a steady 50% share. The rest of the market share is distributed among Gilead’s rivals AbbVie, Johnson and Johnson, and Merck. According to the study conducted by World Health Organization (WHO) in 2014, there are a colossal number of around 37 million people having HIV infection. Out of this enormous number, 60% patients are said having no adequate access to HIV treatment. To this date, no proper cure existed for the life threatening disease. All the extended treatment could only prevent the virus from its multiplication.

Gilead’s flagship market-leader HIV drug collection comprises of Atripla, Complera, Strinild, and Truvada – all of the components are based on Emtriva and Viread. Its first TAF-based HIV therapy, Genvoya’s approval came in November, last year. Now the company has forecast this new combined innovation to generate around $3 billion by 2020.

In addition to it, the company has projected $13.4 billion and $11.2 billion revenue generation from single-tablet and multi-tablet regimens, respectively. However, the pivotal threat hanging along the way of Gilead’s strong HIV dominance is possessed by United Kingdom based GlaxoSmithKline’s ViiV Healthcare unit. Since 2014, GSK’s fiercely competitive single-tablet HIV regimen, Triumeq has been significantly impacting U.S. based organization’s HIV market.

By 2020, Genvoya will generate the revenue worth $2.7 billion while Triumeq has been projected to cultivate revenue of $4.2 billion. Although, Gilead is expected to lag behind GSK in revenue generation from GSK but it is still expected that the U.S. pharma giant will hold 56% worth $14 billion in sales whereas the U.K. biotech company will hold around 28% of the market.