Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency (EMA), has adopted a positive opinion on
the company’s Marketing Authorization Application (MAA) for Zydelig®
(idelalisib 150 mg film-coated tablets), a first-in-class treatment for
patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma
(FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL).
The CHMP opinion supports the use of Zydelig in combination with
rituximab for the treatment of adult patients with CLL who have received
at least one prior therapy or, as first-line treatment in CLL patients
in the presence of 17p deletion or TP53 mutation in patients
unsuitable for chemo-immunotherapy and also as monotherapy for the
treatment of adult patients with FL that is refractory to two prior
lines of treatment. The CHMP’s recommendation will now be reviewed by
the European Commission, which has the authority to approve medicines
for use in the 28 countries of the European Union (EU).
CLL and FL are slow-growing incurable blood cancers that can lead to
life-threatening complications such as anemia, serious infection and
bone marrow failure requiring treatment. Relapse commonly occurs after
initial chemo-immunotherapy and many patients with relapsed CLL or FL
are unable to tolerate chemotherapy, which may limit their treatment
options.
The CHMP positive opinion for Zydelig is based on data from two clinical
trials – Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial,
investigated the efficacy and safety of Zydelig in combination with
rituximab in patients with previously treated CLL. The Phase 2 101-09
study assessed the efficacy and safety of Zydelig in patients with iNHL
who are refractory to rituximab and alkylating agents. Results of Study
116 and Study 101-09 were published in The New England Journal
of Medicine in March 2014.
The most commonly reported adverse reactions (incidence ≥20 percent)
were diarrhea, pyrexia, fatigue, nausea, cough, abdominal pain and
chills. Additionally, grade 3 or 4 elevations in ALT and AST (indicators
of liver function) have been observed in clinical trials of Zydelig.
Grade 3 or 4 pneumonitis and Grade 3 or 4 diarrhea/colitis were also
observed in some patients in the clinical trials.
Zydelig is an investigational product and its safety and efficacy have
not been established in the European Union.
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. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
Asia Pacific.
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 and patients may not see advantages of Zydelig over
other therapies and may therefore be reluctant to prescribe the product.
In addition, European and other regulatory agencies may not approve
Zydelig in the currently anticipated timelines or at all, and any
marketing approvals, if granted, may have significant limitations on its
use. Further, additional studies of Zydelig may produce unfavorable
results. 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 March 31, 2014, 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.
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.
Copyright Business Wire 2014