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It was revealed by Gilead Sciences, Inc that the European Commission nodded on the approval of the marketing authorization of single tablet regimen Odefsey, to manage and treat patients with HIV-1 infection.

Meanwhile, Odefsey is originally based on Descovy, and is a product of Johnson & Johnson (JNJ) subsidiary, which is known as Janssen Sciences Ireland UC. Till date, the drug is regarded as the smallest pill approved to treat HIV infection.   

Earlier in March 2016, the US Food and Drug Administration has approved the molecule, with GILD anticipating that the drug will reach $1.6 billion by the year 2020.

There were signposted for Odefsey in the European Union intended for adults and adolescents, with a body weight of at least 35 kg. The patients must be without mutations relative to the resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) category, tenofovir or emtricitabine, as part of the viral load below 100,000 HIV-1 RNA copies/ml.  

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An MD at North Manchester General Hospital Andy Ustianowski said: “People living with HIV today are increasingly likely to be receiving treatment for other conditions – such as heart and liver disease – because they are living longer than ever before, exposing them for longer periods of time to the virus and to the medications used to treat it. Therefore, we need new treatment options that are not only efficacious, but also tolerable, and with convenient dosing.”

He added: “Odefsey combines the antiviral efficacy and safety profile of the new Descovy backbone with the established tolerability profile of rilpivirine as a third agent.”

Drug’s Approval

The approval of the drug is the outcome of a constant collaboration of Gilead and Janssen in 2009. The agreement implies that Gilead will be held responsible for the management of different factors of the drug like manufacturing, including distribution, and commercialization of Odefsey worldwide.

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However, Janssen will take over for the distribution of the molecule across 18 markets, including the US.

The company anticipates that the HIV franchise can fuel their growth in the near future. Recently, Gilead leads more than 60% of HIV therapeutic market, marking expectations to bring in $18.4 billion by the year 2020.  

The drug pipeline of the company grows rapidly and in a tight competition, as it comprises of investigational molecules, which covers nine therapeutic areas like HIV, cardiology, pulmonology, vaccines, oncology, liver diseases, gastroenterology and endocrinology.

Subsequently, in the segment of immunology, the drugs covers rheumatoid arthritis, including ulcerative colitis, with several mechanism of action like JAK1 inhibitor and MMP9 mAb inhibitors. 

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