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NEW YORK AND INDIANAPOLIS – (BUSINESS WIRE) – Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE: LLY) today
announced preliminary results of a phase 3 study evaluating tanezumab 2.5
mg and 5 mg. The objective of the study was to compare long-term effects
joint safety and efficacy of tanezumab for 16 weeks compared with nonsteroidal therapy
Nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate to severe intolerance.
osteoarthritis of the hip or knee. The treatment arm tanezumab 5 mg
achieved two of the three main efficacy endpoints, demonstrating
statistically significant improvement in pain and physical function
compared to NSAIDs in the 16-week analysis, while the total number of patients
The evaluation of their osteoarthritis was not statistically different from that of NSAIDs.
Patients who received tanezumab 2.5 mg did not show any
statistically significant improvement in pain, physical function, or
the global assessment of osteoarthritis in patients at 16 weeks compared to NSAIDs.
In the analysis of security, there was a higher rate of common security events
in tanezumab arms compared with NSAIDs at 80 weeks; the difference was
statistically significant. Joint safety was a composite measure
consisting of evaluated results of rapidly evolving osteoarthritis
(RPOA) type 1 or type 2, subchondral insufficiency fracture,
osteonecrosis or pathological fracture. Tanezumab is a monoclonal
antibody that is part of an experimental class of chronic non-opioid treatment
pain medications known as nerve growth factor (NGF) inhibitors.
"We analyze these results in the context of the recent phase 3
results as we evaluate potential next steps for tanezumab, "said Ken
Verburg, Head of the Tanezumab Development Team, Pfizer Global Product
Development. "We plan to review all the data from our clinical studies.
tanezumab development program with regulatory authorities. "
"Lilly and Pfizer recognize the significant unmet needs of patients
living with osteoarthritis, "said Christi Shaw, President, Lilly
Biomédicaments. "We are committed to understanding these results for
people who suffer from chronic pain. "
In this study 2.5 mg or 5 mg tanezumab was administered subcutaneously.
(SC) every eight weeks, for a total of 56 weeks. Preliminary security data
showed that the overall profile of the adverse effects of tanezumab was
generally consistent with previous studies on tanezumab in osteoarthritis, although in
In this study, treatment discontinuations due to adverse events were higher in
those receiving tanezumab compared to NSAIDs within 56 weeks
treatment period. The study also included a 24-week safety follow-up
period, for a total of 80 weeks of observation. There were 10 deaths in
l & # 39; study; nine occurred in the arms receiving treatment with tanezumab and one in the
NSAID treatment arm. None were considered treatment-related: five
during the treatment period and five after the
treatment period.
The effect of the main effect criterion on the safety of composite joints was 7.1.
percent in the arm tanezumab 5 mg, 3.8 percent in tanezumab 2.5 mg
1.5% in the arms of NSAIDs. The RPOA represented the majority
events observed in the criterion of effect of the safety of the composite joint. L & # 39; s impact
total of the RPOA was 6.3% in the tanezumab arm 5 mg, 3.2%
in the tanezumab arm to 2.5 mg and 1.2 percent in the NSAID arm. the
the majority of RPOA events (81 percent) observed with tanezumab were RPOAs
type 1. There was a patient with osteonecrosis in tanezumab 5 mg
and no patient in the arms tanezumab 2.5 mg or NSAIDs. Subchondral
Deficiency fracture was observed in seven, six and four patients
receiving tanezumab 5 mg, tanezumab 2.5 mg and NSAIDs, respectively.
No pathological fracture was observed in patients treated with
tanezumab or NSAIDs. The incidence of total joint replacement was 8.0
percent in the arm tanezumab 5 mg, 5.3 percent in tanezumab 2.5 mg
arms and 2.6% in the NSAID arm.
The full results of this study will be submitted to future scientific work.
publication or presentation.
About the study
Study A4091058 was a randomized, double-blind, active-controlled study,
multicenter parallel group study assessing the safety and effectiveness of
Subcutaneous administration of tanezumab for 56 weeks compared to NSAIDs at
patients with moderate to severe osteoarthritis. The study was conducted worldwide
(United States, Europe, Asia and Latin America).
Patients considered for this study had insufficient pain
relief or intolerance to acetaminophen and tramadol or
opioids (or refusing to take opioids). They were taking a stable dose of
NSAIDs before being included in the study and having known at least
some have stable treatment with NSAIDs in the previous period
randomization. On average, patients had suffered osteoarthritis for
approximately eight years old and had benchmark values in western Ontario and McMaster
University Pain Osteoarthritis (WOMAC) scores seven out of seven
10. At the beginning of the study, they also reported a significant
impact of their pain on their ability to function in everyday life.
A total of 3,021 patients were randomized to a ratio of 1: 1: 1 to receive
either tanezumab 2.5 mg every eight weeks, tanezumab 5 mg every eight weeks
Oral NSAIDs (naproxen 500 mg, celecoxib 100 mg or
diclofenac extended-release (75 mg) twice daily for 56 weeks
treatment period. The study also included a 24-week safety follow-up
period.
The main safety criterion assessed a composite measure of
consequences of RPOA type 1 or type 2, subchondral insufficiency fracture,
primary osteonecrosis or pathological fracture for 80 weeks (56
weeks of treatment plus a 24-week safety follow-up period). RPOA type 1
has been defined as a significant loss of articular space width ≥ 2 mm (predicted
optimal articulation) within a period of about one year, without
gross structural failure. RPOA type 2 was defined as abnormal bone loss
or destruction, including the limited or total collapse of at least one
subchondral surface that is not normally present in the
OA in the terminal phase. Primary efficacy evaluation criteria assessed changes
the baseline at week 16 in the WOMAC Pain subscale, the WOMAC Physical
Function and overall assessment of osteoarthritis by the patient.
About Tanezumab
Tanezumab is an experimental monoclonal antibody that works by
selectively targeting, binding to and inhibiting NGF. Levels of NGF
increase in the body as a result of an injury, inflammation or chronic
painful states. By inhibiting NGF, tanezumab can help maintain pain signals
produced by muscles, skin and organs to reach the spinal cord and
brain. Tanezumab has a new mechanism that acts on the periphery in a
differently from opioids and other analgesics, including NSAIDs,
and in the studies conducted to date, tanezumab has not shown any risk of
addiction, abuse or dependency.
In June 2017, Pfizer and Lilly announced that the US market for food and drugs
Administration (FDA) has assigned the Fast Track designation to tanezumab for
the treatment of osteoarthritis and chronic low back pain. The Fast Track designation is
a process designed to facilitate development and speed up the examination
new therapies that treat serious illnesses and fulfill unmet medical treatments
Needs.
About Pfizer Inc .: Working Together for a Healthier World®
At Pfizer, we apply science and our global resources to bring therapies
to people who expand and improve their lives considerably. We strive
set the standard for quality, safety and value in discovery,
development and manufacture of health products. Our global
The drug portfolio includes drugs and vaccines, as well as many medicines on the planet.
most popular consumer health products. Every day, Pfizer colleagues
working in developed and emerging markets to improve well-being,
prevention, treatments and remedies for the most feared diseases
in our time. In keeping with our responsibility to be one of the world leaders
innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable and affordable health care around the world. For
over 150 years, we have worked to make a difference for everyone who
rely on us. We regularly post information that may be important for
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In addition, to learn more, visit www.pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and
Like us on Facebook at Facebook.com/Pfizer.
About Eli Lilly and the company
Lilly is a global leader in the health care industry that combines kindness and discovery for
make life better for people around the world. We have been founded more than
a century ago, by a man committed to creating high quality drugs that
real needs, and today we remain faithful to this mission in all our
job. Around the world, Lilly employees are working to discover and bring
life-changing medicines for those who need them, improve
understanding and management of the disease, and giving back to the communities
through philanthropy and volunteering. To learn more about Lilly, please
Visit us at www.lilly.com and https://www.lilly.com/newsroom/social-channels.
NOTICE OF DISCLOSURE OF PFIZER:
The information contained in this press release is as of April 18, 2019.
Pfizer does not assume any obligation to update forward-looking statements
contained in this press release as a result of new information or future
events or developments.
This release contains forward-looking information about a product
candidate, tanezumab, including its potential benefits, which implies
substantial risks and uncertainties that could lead to actual results
significantly different from those expressed or implied by such statements.
Risks and uncertainties include, among other things, uncertainties
inherent in research and development, including the ability to respond
expected clinical outcomes, start and / or completion dates.
our clinical trials, regulatory submission dates, regulatory approval
dates and / or launch dates, as well as the possibility of new adverse conditions
clinical data and additional analyzes of existing clinical data; the risk
that clinical trial data are subject to different interpretations and
assessments by regulatory authorities; if the regulatory authorities
will be satisfied with the design and results of our clinic
studies; if and when requests for drugs for any potential
indications for tanezumab may be filed in any jurisdiction; if and
where the regulatory authorities of any jurisdiction may approve such
applications, which will depend on a multitude of factors, including the realization of a
determine if the benefits of the product exceed its known benefits
risks and the determination of the effectiveness of the product and, if approved,
if tanezumab will be commercially successful; decisions by
regulatory authorities impacting labeling, manufacturing processes,
security and / or other issues that may affect the availability or
commercial potential of tanezumab; and competitive developments.
A more detailed description of the risks and uncertainties is given in
Pfizer Annual Report on Form 10-K for the year ended December
31, 2018 and subsequent reports on Form 10-Q, including in the
their sections entitled "Risk Factors" and "Prospective Outlook".
Information and factors that may affect future results ", as well as in
its subsequent reports on Form 8-K, all of which are filed with the United States
Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
LILLY DISCLOSURE NOTICE: This press release contains
statements (as this term is defined in the dispute Private Securities Litigation
Reform Act of 1995) on tanezumab as a potential treatment for
patients with osteoarthritis, chronic low back pain and cancer,
and reflects Lilly's current beliefs. However, as for all
pharmaceutical product, there are significant risks and uncertainties in
process of drug development and commercialization. Among others
there is no guarantee that the results of future studies will be
consistent with the results of the study to date, or that tanezumab will be
approved by the US FDA or other regulatory authorities on the
planned or at all, or that tanezumab be commercially
successful. For a more in-depth discussion of these and other risks, and
Uncertainties, see Lilly's most recent documents on Forms 10-K and 10-Q.
with the Securities and Exchange Commission of the United States. Except that
required by law, Lilly assumes no obligation to update prospectively
statements reflecting events subsequent to the date of this publication.
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