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2014-06-12

AstraZeneca: US FDA Ad Com recommends no cardiovascular outcomes trial for peripherally-acting mu-opioid receptor antagonist (PAMORA) class including MOVANTIK

AstraZeneca announced today that the majority of US Food and Drug
Administration (FDA) Anesthetic and Analgesic Drug Products Advisory
Committee (AADPAC) members voted that the FDA should not require
cardiovascular outcomes trials for the peripherally-acting mu-opioid
receptor antagonist (PAMORA) class of drugs, which includes
MOVANTIKTM (naloxegol oxalate), an investigational treatment for
opioid-induced constipation (OIC) for patients with chronic
non-cancer pain. Following a clarification of the vote, the majority
of the Committee suggested continued post-approval data collection
for cardiovascular safety.

The FDA convened a meeting of the AADPAC to review the class of
peripherally acting opioid receptor antagonists on 11-12 June 2014.
The meeting assessed the necessity, timing, design and size of
cardiovascular outcomes trials to support approval of products in the
class, for the proposed indication of OIC in patients taking opioids
for chronic non-cancer pain. The FDA is not bound by the Advisory
Committee's recommendation, but takes its advice into consideration
when reviewing applications for investigational medicines. The
Prescription Drug User Fee Act (PDUFA) date set by the FDA for
MOVANTIK is 16 September 2014.

Briggs Morrison, Executive Vice President, Global Medicines
Development and Chief Medical Officer said: "We are pleased that the
Committee did not find it necessary to require a cardiovascular
outcomes trial for the PAMORA class. We look forward to the outcome
of the FDA's review of the New Drug Application for MOVANTIK and the
potential to provide patients with chronic non-cancer pain affected
by OIC with an additional treatment option."

Opioids play an important role in chronic pain relief by binding
mu-receptors in the brain, but they also bind mu-receptors in the
bowel. That is why patients taking opioids for chronic pain can
develop OIC. In fact, the incidence of OIC can be as high as 81% in
patients taking opioids. There is a significant unmet need for safe,
effective treatment options for patients with OIC. An estimated 235
million prescriptions for opioids are written in the US each year, of
which 20% are for chronic pain. For patients taking prescription
opioids for chronic pain, constipation is one of the most common side
effects and one not adequately relieved by laxatives.

If approved, MOVANTIK has the potential to be the first once-daily,
oral PAMORA for the treatment of OIC for patients with chronic
non-cancer pain. MOVANTIK is also under regulatory review with health
agencies in the European Union and Canada.

On 4 June 2014 the New England Journal of Medicine published data
online from two pivotal Phase III studies of MOVANTIK, KODIAC-4 and
KODIAC-5. Both studies met their primary endpoint, showing an
improvement in treatment effect versus placebo: more OIC non-cancer
pain patients treated with MOVANTIK at a 25 mg dose had a consistent
response of increased spontaneous bowel movements through 12 weeks of
treatment compared to placebo.

-ENDS-

NOTES TO EDITORS

About MOVANTIKTM (naloxegol oxalate)

MOVANTIK is an investigational peripherally-acting mu-opioid receptor
antagonist (PAMORA) specifically designed for the treatment of
opioid-induced constipation (OIC) in patients with chronic non-cancer
pain. In the Phase III clinical studies, MOVANTIK was administered as
a once-daily tablet and is designed to block the binding of opioids
to the opioid receptors in the gastrointestinal (GI) tract without
impacting the opioid receptors in the brain.

MOVANTIK is part of the exclusive worldwide licence agreement
announced on 21 September 2009, between AstraZeneca and Nektar
Therapeutics. MOVANTIK was developed using Nektar's oral small
molecule polymer conjugate technology.

About Opioid-Induced Constipation (OIC)

Opioids play an important role in chronic pain relief by binding
mu-receptors in the brain. But they also bind mu-receptors in the
bowel. That is why patients taking opioids for chronic pain can
develop opioid-induced constipation (OIC). In fact, the incidence of
OIC varies and has been reported as high as 81% in patients taking
opioids.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit:
www.astrazeneca.com

CONTACTS

Media Enquiries

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Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

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