European CHMP Adopts Positive Opinion for Gilead’s Zydelig® (idelalisib) for
the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma
FOSTER CITY, Calif. -- July 25, 2014
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.
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 endedMarch 31, 2014,
as filed with theU.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.
Gilead Sciences, Inc.
Patrick O’Brien, Investors
Arran Attridge, Media (EU)
+44(0)20 8587 2477
Nathan Kaiser, Media (US)
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