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FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection

FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 10, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. See below for important safety information.

Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300mg. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.

“Chronic hepatitis B is a life-threatening illness that affects up to 2.2 million people in the U.S.,” said Calvin Pan, MD, Clinical Professor of Medicine, NYU Langone Medical Center, and investigator in the Vemlidy clinical trials. “Clinical trials demonstrated Vemlidy is efficacious with improved renal and bone safety parameters compared to Viread, representing an important development for people living with this chronic disease.”

Vemlidy’s approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either Vemlidy or Viread, and Study 110 randomized and treated 873 HBeAg-positive patients with either Vemlidy or Viread. Both studies met their primary endpoint of non-inferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.

In an integrated analysis of both studies, patients receiving Vemlidy demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with Viread. Patients in the Vemlidy arm also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (ALT) levels.

Vemlidy and Viread were generally well-tolerated by patients in both studies and discontinuations due to adverse events were 1% and 1.2%, respectively. The most commonly reported adverse events in both studies included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or Viread.

“Since the mid-1990s, Gilead has been working to improve and simplify care for people living with chronic hepatitis B,” said John Milligan, Ph.D., President and Chief Executive Officer of Gilead Sciences. “Vemlidy is the first medication approved to treat this disease in nearly a decade, and we are excited to offer a new, effective option to help advance long-term care for patients.”

Additional data on TAF will be presented at The Liver Meeting® 2016 in Boston.

U.S. Patient Support Program

Gilead’s U.S. Advancing Access® patient support program provides information regarding access and reimbursement coverage options to patients in the United States who need assistance with coverage for their medications, including Vemlidy.

Advancing Access conducts Vemlidy benefits investigations and provides patients with information regarding their insurance options. Further, the Vemlidy Co-pay Coupon Program offers co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.

Information about how to enroll can be found at https://AdvancingAccessConsent.iassist.com/ or by calling 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. (Eastern).

Global Availability

Gilead is committed to helping enable access to Vemlidy for all people in need, regardless of where they live or what resources they have. Since 2003, the company has operated a dedicated business unit focused on expanding access to medicines in lower-income countries. Gilead works with regional business partners on local country regulatory submissions to provide branded HBV drugs at reduced prices in 125 low- and middle-income countries. Gilead has also established licensing agreements with 19 generic drug manufacturers in India, South Africa and China, as well as the Medicines Patent Pool, granting them rights to produce and sell high-quality, low-cost generic versions of Gilead HBV medicines in 112 developing countries. Vemlidy is already an integrated component of the company’s generic licensing agreements, and with FDA approval, manufacturing partners may begin production and distribution of a generic version of this medicine.



Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs.

Discontinuation of anti-hepatitis B therapy, including Vemlidy, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including Vemlidy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Warnings and Precautions

Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, Vemlidy alone is not recommended for the treatment of HIV-1 infection. Safety and efficacy of Vemlidy have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with Vemlidy, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.

New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of Vemlidy, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Vemlidy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, fatigue, cough, nausea and back pain.

Drug Interactions

Coadministration of Vemlidy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.

Coadministration of Vemlidy is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of Vemlidy. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for Vemlidy for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

Dosage: Adults; one tablet taken once daily with food.

Renal Impairment: Not recommended in patients with CrCl <15 mL/min.

Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

Testing prior to initiation: HIV infection.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Vemlidy for the treatment of chronic HBV. In addition, Gilead may be unable to obtain regulatory approval for Vemlidy for the treatment of chronic HBV from other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statement.

U.S. full prescribing information for Vemlidy, including BOXED WARNING, is available at www.gilead.com.

VEMLIDY, VIREAD, and ADVANCING ACCESS are trademarks of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000

Source: Gilead Sciences, Inc., Drugs.com https://www.drugs.com/newdrugs/fda-approves-gilead-s-vemlidy-tenofovir-alafenamide-chronic-hepatitis-b-virus-infection-4452.html?utm_source=ddc&utm_medium=email&utm_campaign=FDA+Approves+Gilead%E2%80%99s+Vemlidy+%28tenofovir+alafenamide%29+for+the+Treatment+of+Chronic+Hepatitis+B+Virus+Infection

Posted: November 2016

FDA Approves Intrarosa (prasterone) for Postmenopausal Women Experiencing Dyspareunia

FDA Approves Intrarosa (prasterone) for Postmenopausal Women Experiencing Dyspareunia

November 17, 2016 -- The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”

Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease.

Intrarosa is marketed by Quebec-based Endoceutics Inc.

Source: FDA, Drugs.com https://www.drugs.com/newdrugs/fda-approves-intrarosa-prasterone-postmenopausal-women-experiencing-dyspareunia-4455.html?utm_source=ddc&utm_medium=email&utm_campaign=FDA+Approves+Intrarosa+%28prasterone%29+for+Postmenopausal+Women+Experiencing+Dyspareunia

Posted: November 2016

Alkermes Positive Phase 3 Study Results Spells Good News for Major Depressive Disorder Space

Fri, 11/11/2016 - 8:51am

by Christos Michaelides, Ph.D., Neurology and Opthamology Analyst, GlobalData

Positive topline results have been announced by Alkermes for its Phase III study of ALKS-5461 as an adjunctive therapy for major depressive disorder (MDD), according to research and consulting firm GlobalData.

As explored in GlobalData’s most recent MDD report, ALKS-5461 is one of six late-stage pipeline products showing promise with regards to improving efficacy and safety in the treatment of patients with the disorder. In October 2013, ALKS-5461 was granted fast track designation by the FDA for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.

This status will both facilitate and expedite the FDA developmental and regulatory review process for ALKS-5461, which GlobalData anticipates will enter the US market in early 2018.

Current treatment options for MDD tend to rely on selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors; however, these antidepressants are not ideal, as approximately one third of patients do not demonstrate any remission of symptoms. Those who do not respond to two or more antidepressant therapies are referred to as ‘treatment-resistant,’ and ALKS-5461 is aimed towards providing a therapy for these patients.

Although ALKS-5461 has a novel mechanism of action that is expected to provide benefit to MDD patients, it is expected that patient uptake may be negatively impacted by the outcomes of previous Phase III trials, which have been less positive. Furthermore, the drug is likely to find itself facing competition from other emerging pipeline therapies that have demonstrated more robust efficacy in treatment-resistant patients, such as Janssen’s esketamine or Allergan’s rapastinel.

The risk of dependency due to ALKS-5461’s action through the opioid system is also a concern, which may compromise uptake. However, such concerns may already be mitigated through the demonstrated supportive clinical data showing that there was no difference in abuse potential between ALKS-5461 and placebo.

Source: Drug Discovery & Development http://www.dddmag.com/article/2016/11/alkermes-positive-phase-3-study-results-spells-good-news-major-depressive-disorder-space?et_cid=5671205&et_rid=1049968299&type=cta&et_cid=5671205&et_rid=1049968299&linkid=content

J&J Vaccine Plus Gilead Immune Booster Shows Promise as HIV Fighter

An experimental HIV vaccine from Johnson & Johnson combined with an immune system booster from Gilead Sciences Inc showed promise at keeping the virus at bay in monkeys even after treatments had stopped, marking yet another step toward the development of a so-called functional cure for HIV.

Both companies are currently testing the products separately in early-stage trials in people with HIV.

Read more.

Source: Reuters, from Drug Discory & Development Newsletter http://www.dddmag.com/industry-brief/2016/11/j-j-vaccine-plus-gilead-immune-booster-shows-promise-hiv-fighter?et_cid=5671205&et_rid=1049968299&type=cta&et_cid=5671205&et_rid=1049968299&linkid=content

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