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|Amgen And AstraZeneca To Present Results From Phase 3 AMAGINE-1™ Study Evaluating Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis|
"We are excited to present additional data from AMAGINE-1, which provide further insight into brodalumab's potential role in addressing the unmet needs of patients living with psoriasis," said
The AMAGINE-1 trial assessed the safety and efficacy of brodalumab given every two weeks via subcutaneous injection at two doses (140 mg or 210 mg) compared with placebo after 12 weeks of treatment in patients with moderate-to-severe plaque psoriasis. Another purpose of the study was to assess safety and efficacy when patients treated with brodalumab, who responded to treatment, continued receiving brodalumab compared to patients who had treatment withdrawn and began receiving placebo. Data being presented include results through week 52.
The AMAGINE program comprises three pivotal Phase 3 studies designed to assess the efficacy and safety of brodalumab in more than 4,200 patients with moderate-to-severe plaque psoriasis. Positive top-line results from AMAGINE-1 were released in
About Brodalumab (AMG 827)
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
Stelara® is a registered trademark of
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/amgen-and-astrazeneca-to-present-results-from-phase-3-amagine-1-study-evaluating-brodalumab-in-patients-with-moderate-to-severe-plaque-psoriasis-300008735.html