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2016-06-06

Sanofi : Sanofi and Regeneron Announce that Dupilumab Used with Topical Corticosteroids (TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Tria

Sanofi and Regeneron Announce that Dupilumab Used with Topical Corticosteroids
(TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Trial in
Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients

- These data, along with previous Phase 3 studies, will be part of a U.S.
regulatory submission for dupilumab, which is on track for Q3 of 2016 -

Paris, France, and Tarrytown, N.Y. - June 6
, 2016
-Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that a one-year Phase 3 study, known as LIBERTY AD CHRONOS, evaluating
investigational dupilumab met its primary and key secondary endpoints. In the
study, dupilumab with topical corticosteroids (TCS) was compared to TCS alone
in moderate-to-severe atopic dermatitis (AD) adult patients. Patients
enrolled in the study were inadequately controlled by topical corticosteroids
(TCS) with or without topical calcineurin inhibitor (TCI). Dupilumab with TCS
significantly improved measures of overall disease severity at 16 and 52
weeks, when compared to placebo with TCS.

"These are the first long-term Phase 3 data that demonstrated dupilumab with
topical corticosteroids
was superior to topical corticosteroids alone, and provided sustained
efficacy, significantly improving measures of overall disease severity, skin
clearing, itching, and quality of life through one year of treatment,"
said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron
and President of Regeneron Laboratories."Although topical corticosteroids are
standard therapies for atopic
dermatitis, they are non-specific anti-inflammatory agents, while dupilumab
is a targeted therapy that specifically blocks the IL-4/IL-13 signaling
pathway. Our collective clinical data demonstrate that this pathway is a root
cause in atopic dermatitis, asthma and nasal polyposis and we continue to
evaluate the potential of this pathway in these atopic and allergic
diseases."

"Dupilumab is an innovative first-in-class investigational agent that has
shown significant efficacy and a favorable safety profile in two pivotal
Phase 3 studies in monotherapy for moderate-to-severe atopic dermatitis, and
now in concomitant administration with topical corticosteroids,"
said Elias Zerhouni, M.D., President, Global R&D, Sanofi."These one-year data
strengthen the earlier 16-week results, suggesting that
dupilumab impacts the aberrant activation of the IL-4/IL-13 pathway which
resulted in significant efficacy without the side effects associated with
immune-suppressing therapies. We will continue to advance dupilumab for
patients worldwide suffering from inadequately controlled moderate-to-severe
atopic dermatitis, with the first regulatory submission planned in the U.S.
for the third quarter of this year."

The primary endpoint results at week 16 were the following:

* 39 percent of patients who received either dupilumab 300 mg weekly or
dupilumab 300 mg every two weeks with TCS achieved clearing or
near-clearing of skin lesions (IGA 0 or 1), compared to 12 percent of
patients receiving placebo with TCS (p less than 0.0001).
* 64 percent of patients who received dupilumab 300 mg weekly with TCS, and
69 percent of patients who received dupilumab 300 mg every two weeks with
TCS achieved EASI-75, compared to 23 percent of patients receiving placebo
with TCS (p less than 0.0001).

The secondary endpoint 52-week results were the following:

* 40 percent of patients who received dupilumab 300 mg weekly with TCS, and
36 percent of patients who received dupilumab 300 mg every two weeks with
TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1),
compared to 12.5 percent of patients receiving placebo with TCS (p less
than 0.0001).
* 64 percent of patients who received 300 mg weekly with TCS, and 65 percent
of patients who received 300 mg every two weeks with TCS achieved EASI-75,
compared to 22 percent with placebo with TCS (p less than 0.0001).

Patients were less likely to discontinue therapy in the dupilumab with TCS
groups compared to placebo with TCS group (15 percent in both dupilumab
groups; 33 percent placebo).

The overall rate of adverse events was comparable between the dupilumab with
TCS groups (83 percent for the weekly dose and 88 percent for the every two
weeks dose) and the placebo with TCS group (84 percent). The rate of serious
adverse events was comparable between the dupilumab with TCS groups (3 and 4
percent) and placebo with TCS group (5 percent). Serious and/or severe
infections were numerically higher in the placebo with TCS group (1 percent
in both dupilumab groups and 2 percent placebo). Adverse events that were
noted to have a higher rate with dupilumab included injection site reactions
(20 and 16 percent dupilumab; 9 percent placebo) and conjunctivitis (19 and
13 percent dupilumab; 8 percent placebo); 22 percent of patients on placebo,
and 23 and 28 percent of patients on dupilumab reported a history of allergic
conjunctivitis at study entry.
More detailed results, including long-term efficacy and safety data from
CHRONOS will be submitted for presentation at a future medical congress.

The U.S. Food and Drug Administration (FDA) granted dupilumab Breakthrough
Therapy designation in AD in November 2014. Dupilumab is currently under
clinical development and its safety and efficacy have not been fully
evaluated by any regulatory authority. If approved, dupilumab would be
commercialized by Regeneron and Sanofi Genzyme, the specialty care global
business of Sanofi.

The LIBERTY AD Phase 3 clinical program consists of five trials of patients
with moderate-to-severe AD at sites worldwide.

About the LIBERTY CHRONOS TRIAL

A total of 740 adult patients with moderate-to-severe AD were enrolled in
CHRONOS. All patients were inadequately controlled with topical medications
and were assessed via the 5-point Investigator's Global Assessment (IGA)
scale, ranging from 0 (clear) to 4 (severe); entry criteria required a
baseline score of 3 or 4. Patients were also assessed using the Eczema Area
and Severity Index (EASI) and other measures. All patients initiated daily
treatment with a medium potency TCS or low potency TCS on areas of the body
where medium potency TCS is considered unsafe. Patients were randomized in a
3:1:3 fashion into the following treatment groups: dupilumab 300 mg
subcutaneously once per week (n=319), dupilumab 300 mg subcutaneously every
two weeks (n=106), or placebo (n=315). This design allowed sufficient power
for the efficacy endpoints in both dupilumab groups while increasing the
available safety data on the more frequent dosing regimen. In the U.S., the
primary efficacy endpoint of the study was the percent of patients who
achieved IGA 0 or 1 at 16 weeks. In Europe and Japan there was an additional
co-primary endpoint: the percent of patients achieving an EASI 75 score at
week 16. The primary analysis was pre-specified to occur 52 weeks after
approximately 85 percent of patients were randomized into the study.

About Atopic Dermatitis

Atopic dermatitis - a serious form of eczema - is a chronic inflammatory
disease characterized by itchy, inflamed skin that can be present on any part
of the body.1,2Though symptoms appear externally, atopic dermatitis is
characterized by underlying inflammation.3About 70 percent of people with
atopic dermatitis have a family history of other common atopic diseases, such
as asthma or hay fever.2,8In many cases, atopic dermatitis is characterized
by pruritus (itchiness) and skin lesions.9,10,11The intense itching,
scratching and skin damage associated with the disease can cause secondary
infections that may require additional treatments. In addition, the physical
manifestations of the disease can lead to anxiety, depression, and feelings
of social isolation.12,13,14,15,16Based on a survey of 200 physicians, there
are approximately 1.6 million patients in the U.S. that have been diagnosed
with moderate-to-severe atopic dermatitis, and are currently being treated
but still are living with inadequately controlled disease.7

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi is organized into
five global business units: Diabetes and Cardiovascular, General Medicines
and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is
listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating
diseases that are often difficult to diagnose and treat, providing hope to
patients and their families.

About Regeneron Pharmaceuticals, Inc.

Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company
based in Tarrytown, New York that discovers, invents, develops, manufactures,
and commercializes medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for high LDL cholesterol, eye diseases,
and a rare inflammatory condition and has product candidates in development
in other areas of high unmet medical need, including oncology, rheumatoid
arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For
additional information about the company, please visitwww.regeneron.comor
follow @Regeneron on Twitter.

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services, product
development and potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and similar
expressions. Although Sanofi's management believes that the expectations
reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties inherent in
research and development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or biological
application that may be filed for any such product...

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