ARIAD Announces Submission of Marketing Authorization Application for Brigatinib to the European Medicines Agency
06 Febrero 2017 - 6:35AM
Business Wire
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the
submission of a Marketing Authorization Application (MAA) for its
investigational oral anaplastic lymphoma kinase (ALK) inhibitor,
brigatinib, to the European Medicines Agency (EMA). ARIAD is
seeking marketing approval in the European Union of brigatinib in
adult patients with anaplastic lymphoma kinase (ALK+) non-small
cell lung cancer (NSCLC) who have been previously treated with
crizotinib. The U.S. Food and Drug Administration (FDA) is
currently reviewing a New Drug Application for brigatinib filed by
ARIAD and has set an action date of April 29, 2017 under the
Prescription Drug User Fee Act (PDUFA).
“ARIAD's submission of the brigatinib MAA to the
EMA is one of many recent milestones highlighting our
strong investment in internally discovered rare cancer
therapies,” said Paris Panayiotopoulos, president and chief
executive officer of ARIAD. “Since announcing our definitive
agreement to combine with Takeda, we remain focused on our
accountability to our patients by propelling brigatinib forward and
by preparing for its anticipated U.S. launch.”
“The brigatinib clinical trials have provided patients with
refractory ALK+ NSCLC, including those patients who have metastatic
brain lesions, with a potential important treatment option,” said
Maurice Perol, MD, Léon Bérard Cancer Center, Lyon, France. “Based
on the clinical data we’ve seen to date, we are really excited by
the prospect that appropriate patients in the EU may have access to
brigatinib as a new targeted treatment.”
ARIAD’s MAA submission includes clinical data from its Phase 1/2
and pivotal Phase 2 ALTA trials of brigatinib. Results from the
ALTA trial and central nervous system (CNS) activity in the ALTA
and Phase 1/2 trials were reported at the International Association
for the Study of Lung Cancer (IASLC) 17th World
Conference on Lung Cancer (WCLC) in December 2016. In the ALTA
trial, 222 patients received either 90 mg of brigatinib once per
day (QD) continuously or 180 mg QD, preceded by a lead-in dose of
90 mg QD for seven days. Data from the ALTA trial demonstrated that
of 110 patients on the 180-mg regimen QD with a seven-day lead-in
at 90 mg QD with a median follow-up of 11.0 months, 55 percent
achieved confirmed objective response as assessed by the
investigator. In this arm, the median progression-free survival
(PFS) was 15.6 months in this post-crizotinib setting, by both
investigator and independent review committee (IRC) assessment.
Additionally, in this arm, 67 percent (12/18) of patients with
measurable brain metastases achieved a confirmed intracranial
objective response. The most common treatment-emergent adverse
events (TEAEs; ≥ 25% of all patients in this arm, regardless of
relationship to treatment), were nausea (43%), fatigue (40%),
diarrhea (39%), cough (36%), increased blood creatine phosphokinase
(CPK) (33%), headache (30%), rash (28%), and vomiting (26%). The
most common serious adverse reactions other than neoplasm
progression reported in 2% or more of patients included pneumonia
(5.0%), pneumonitis (5.0%) and epilepsy (2.3%). A subset of
pulmonary adverse events (AEs) with early onset (median: Day 2;
range: Day 1-9) occurred in 6.4 percent of all patients (grade ≥3
in 3% of patients); no such events with early onset occurred after
dose escalation to 180 mg QD following the lead-in dose of 90 mg
for seven days.
About Brigatinib
Brigatinib is an investigational, targeted cancer medicine
discovered internally at ARIAD. It is in development for the
treatment of patients with anaplastic lymphoma kinase positive
(ALK+) non-small cell lung cancer (NSCLC). The global Phase 2 ALTA
trial, in patients with locally advanced or metastatic ALK+ NSCLC
who were previously treated with crizotinib, is the primary basis
for brigatinib’s initial regulatory review. ARIAD has also
initiated the Phase 3 ALTA 1L trial to assess the efficacy and
safety of brigatinib in comparison to crizotinib in patients with
locally advanced or metastatic ALK+ NSCLC who have not received
prior treatment with an ALK inhibitor. More information on
brigatinib clinical trials can be found here.
Brigatinib received Breakthrough Therapy designation from the
FDA for the treatment of patients with ALK+ NSCLC whose tumors are
resistant to crizotinib, and was granted Orphan Drug designation by
the FDA for the treatment of ALK+, ROS1+ and EGFR+ NSCLC.
About ALK+ NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of
lung cancer, accounting for approximately 80 to 85 percent of the
estimated 222,500 new cases of lung cancer diagnosed each year in
the United States, according to the American Cancer Society.
Anaplastic lymphoma kinase (ALK) was first identified as a
chromosomal rearrangement in anaplastic large-cell lymphoma (ALCL).
Genetic studies indicate that chromosomal rearrangements in ALK are
key drivers in a subset of NSCLC patients as well. Approximately
five percent of patients with NSCLC have a rearrangement in the ALK
gene, according to the American Cancer Society.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is focused on discovering, developing and
commercializing precision therapies for patients with rare cancers.
ARIAD is working on new medicines to advance the treatment of rare
forms of chronic and acute leukemia, lung cancer and other rare
cancers. On January 9, 2017, it was announced that ARIAD has
entered into a definitive agreement to be acquired by Takeda. The
transaction is expected to close by the end of February 2017,
subject to customary closing conditions. For additional
information, visit http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
Forward-Looking Statements
This press release contains forward-looking statements. Any
statements contained herein which do not describe historical facts,
including, but not limited to, statements regarding regulatory
filings for brigatinib and the therapeutic potential of brigatinib,
the anticipated timing for approval of brigatinib in the United
States, the announced merger between ARIAD and Takeda, ARIAD’s
continued efforts to develop brigatinib, ARIAD’s plans for the
potential U.S. launch of brigatinib, and the potential of
brigatinib as a new treatment option, are forward-looking
statements which are based on management's expectations and are
subject to certain factors, risks and uncertainties that may cause
actual results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements.
These factors, risks and uncertainties include, among others: risks
related to the satisfaction of the conditions to closing the Takeda
acquisition (including the failure to obtain necessary regulatory
approvals) in the anticipated timeframe or at all, including
uncertainties as to how many of ARIAD’s stockholders will tender
their shares in the tender offer and the possibility that the
acquisition does not close; early-stage clinical data may not be
replicated in later-stage clinical studies; the costs associated
with our research, development, manufacturing and other activities;
the adequacy of our capital resources and the availability of
additional funding; our ongoing and additional clinical trials of
brigatinib may not be successful or initiated, enrolled or
conducted in a timely manner; our ability to meet anticipated
regulatory filing and approval dates for brigatinib; regulatory
developments and safety issues, including difficulties or delays in
obtaining regulatory and pricing and reimbursement approvals for
brigatinib; competitive risks; manufacturing issues; the
uncertainties inherent in research and development, including the
ability to sustain and increase the rate of growth in revenues for
ARIAD’s products despite increasing competitive, reimbursement and
economic challenges; whether and when any drug applications may be
filed in any jurisdictions for any indications or any additional
indications for ARIAD’s products or for ARIAD’s pipeline assets;
whether and when the FDA, EMA or any other applicable
regulatory authorities may approve any such applications, which
will depend on its assessment of the benefit-risk profile suggested
by the totality of the efficacy and safety information submitted;
decisions by the FDA, EMA or other regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of ARIAD’s products and
ARIAD’s pipeline assets; and competitive developments; and those
additional factors detailed in our public filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and subsequent quarterly and current
reports on Form 10-Q and Form 8-K. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release. All forward‐looking statements in this press release are
qualified in their entirety by this cautionary statement.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170206005112/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet Soni,
617-503-7298manmeet.soni@ariad.comorFor MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
Ariad (NASDAQ:ARIA)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Ariad (NASDAQ:ARIA)
Gráfica de Acción Histórica
De May 2023 a May 2024