Amgen, Inc. (NASDAQ:AMGN) is pleased to announce that U.S. Food And Drug Administration had accepted its supplemental Biologics License Application for the expanded use of etanercept (Enbrel). As per the reports, it can be utilized for the treatment of pediatric patients suffering from chronic severe plaque psoriasis.
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The senior management team of Amgen is pleased to share this update with all the investors and hopes that things will continue to fall in line in the coming months as well. According to Sean E. Harper, M.D., EVP – R&D, Amgen, there are thousands of chronic severe plaque psoriasis in pediatric patients in the United States. If approved, ENBREL can put an end to their misery without any hassle. The objective of Amgen is to offer suitable treatment to patients as and when there’s an unmet need for medical assistance.
The supplemental Biologics License Application was first submitted on January 5, 2016. It’s based on the results achieved in Phase 3 one-year study for evaluating the efficacy and safety of ENBREL in all the pediatric patients with severe or moderate plaque psoriasis.
A lot of incidents in the medical field have taken place lately, which have prompted FDA not to leave any stone unturned this time. As per the reports, FDA has decided to keep Prescription Drug User Fee Act target action to date on November 5, 2016, before which no action will be taken. It will try to make a note of all the aspects to come up with the best possible decision for the company as well as the patients.
Reporters attempted to get in touch with Amgen staff, but nobody other than the EVP Sean E. Harper spoke about this issue. Going forward, it will be great to see how FDA treat this matter and come up with a decision that’s right for everyone.