Japan’s Ministry of Health, Labour & Welfare Approves Gilead’s Vemlidy® for Patients With Chronic Hepatitis B Virus Infe...
December 19 2016 - 2:03AM
Business Wire
-- A Once-Daily Treatment that
Demonstrated Comparable Efficacy with Improved Renal and Bone
Laboratory Safety Parameters Compared to Tenofovir Disoproxil
Fumarate (TDF) --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
Japanese Ministry of Health, Labour and Welfare (MHLW) has approved
Vemlidy® (tenofovir alafenamide) 25mg, a once-daily treatment for
suppression of viral replication in chronic hepatitis B patients
with evidence of hepatitis B virus replication and abnormal liver
function.
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 tenofovir disoproxil fumarate (TDF) 300mg. Data
show that Vemlidy has greater plasma stability and delivers
tenofovir to hepatocytes more efficiently compared to TDF. As a
result, Vemlidy can be given at a lower dose, reducing the
concentration of tenofovir in the bloodstream. Vemlidy has also
shown improvements in renal and bone laboratory safety parameters
compared to TDF.
"It is very exciting that a new treatment with improvements in
renal and bone safety parameters is now approved for patients with
chronic hepatitis B. This is an important advancement, as these
patients often require lifelong therapy," said Namiki Izumi, MD,
the President of Musashino RedCross Hospital.
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
HBeAg-negative and HBeAg-positive chronic HBV infection. Study 108
randomized and treated 425 HBeAg-negative patients with either
Vemlidy or TDF, and Study 110 randomized and treated 873
HBeAg-positive patients with either Vemlidy or TDF. Study 108
enrolled 27 patients from 11 sites in Japan and Study 110 enrolled
46 patients from 16 sites in Japan. Both studies met their primary
endpoint of non-inferiority to TDF 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 bone and renal laboratory
parameters compared to those treated with TDF. Patients in the
Vemlidy arm also experienced numerically higher rates of
normalization of serum alanine aminotransferase (ALT) levels.
Vemlidy and TDF were generally well-tolerated by patients in
both studies and discontinuations due to adverse events were 1% and
1.2%, respectively. In both studies, the most commonly reported
adverse events included headache, abdominal pain, fatigue, cough,
nausea and back pain and occurred at similar rates in patients
receiving either Vemlidy or TDF.
“There are currently more than one million people in Japan
chronically infected with hepatitis B, and we believe Vemlidy is an
important option for patients living with this disease,” said
Norbert Bischofberger, PhD, Gilead’s Executive Vice President,
Research and Development, and Chief Scientific Officer. “We have
been pleased to partner with the medical community here in Japan to
demonstrate the efficacy and safety profile of Vemlidy, and we look
forward to making the medication available in Japan soon.”
Gilead is now preparing to launch Vemlidy as quickly as
possible.
In Japan, TDF is sold by GlaxoSmithKline K.K.
Important Safety Information and
Indication for Vemlidy in the U.S.
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS
B
- 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; 1 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.
Indication
VEMLIDY is indicated for the treatment of chronic hepatitis B
virus (HBV) infection in adults with compensated liver disease.
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.
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. 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 statements.
U.S. full prescribing information for Vemlidy,
including BOXED WARNING, is available at www.gilead.com.
Vemlidy is a registered trademark 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
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Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792Media
(Japan)Seiko Noma, 81-(3)-6837-0790Media (U.S.)Kelsey Grossman,
650-378-2103
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