Blog Exposure - EMA Scientific Committee Recommended Granting Marketing Authorization to Gilead's Biktarvy(R) for HIV-1 Treatment

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LONDON, UK / ACCESSWIRE / May 01, 2018 / Active-Investors.com has just released a free research report on Gilead Sciences, Inc. (NASDAQ: GILD). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=GILD as the Company's latest news hit the wire. On April 27, 2018, the Company announced that the European Medicines Agency (EMA)'s scientific group, Committee for Medicinal Products for Human Use (CHMP), recommended granting approval to Marketing Authorization Application (MAA) for Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Gilead Sciences most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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The CHMP's recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Iceland, and Liechtenstein. A EC decision is expected in mid-2018.

If Approved, Biktarvy® would be Fifth TAF-Based Product for HIV in EU in Past Three Years

Andrew Cheng, MD, PhD, Chief Medical Officer of Gilead Sciences, stated that triple therapy has been the standard of HIV treatment for more than 20 years and has allowed people living with HIV to achieve durable undetectability. Andrew mentioned that if approved, Biktarvy® would be the fifth TAF-based product for HIV in the European Union (EU) in the past three years, and because of its drug interaction profile, minimal monitoring requirements and ease of administration, the Company believes it could represent a meaningful advance in HIV treatment for appropriate patients in Europe.

FDA Approved Biktarvy® for Treatment of HIV-1 Infection

On February 07, 2018, the US Food and Drug Administration (FDA) approved Biktarvy® for the treatment of HIV-1 infection. The FDA approval and MAA for BIC/FTC/TAF is supported by data from four ongoing Phase-3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. Biktarvy® met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no patients discontinued Biktarvy® due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking Biktarvy® were diarrhea, nausea, and headache.

Gilead Presented Phase-3 Study Results of Patients Who Switched to Biktarvy® from Regimen Containing Abacavir, Dolutegravir, and Lamivudine

On March 05, 2018, the Company announced detailed 48-week results from a Phase-3 study (Study 1844) evaluating the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) to Biktarvy®. Through Week 48, Biktarvy® was found to be statistically non-inferior to ABC/DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance.

About Biktarvy®

Biktarvy® is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy®.

About Gilead Sciences, Inc.

Founded in 1987 and headquartered in Foster City, California, Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The Company's scientific focus has resulted in 23 marketed products that are benefiting millions of people.

Stock Performance Snapshot

April 30, 2018 - At Monday's closing bell, Gilead Sciences' stock declined 2.21%, ending the trading session at $72.23.

Volume traded for the day: 8.16 million shares, which was above the 3-month average volume of 7.77 million shares.

Stock performance in the past twelve-month period – up 5.37%; and year-to-date - up 0.82%

After yesterday's close, Gilead Sciences' market cap was at $94.40 billion.

Price to Earnings (P/E) ratio was at 9.40.

The stock has a dividend yield of 3.16%.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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