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www.fdanews.com/articles/176324-fda-issues-crl-to-chiasma-requests-more-data-on-mycapssa

FDA Issues CRL to Chiasma, Requests More Data on Mycapssa

April 22, 2016

The FDA has thrown a wrench into Chiasma’s plans to market Mycapssa, the company’s acromegaly candidate, issuing a complete response letter that asks for more data.

The agency expressed a number of concerns related to its pivotal trial that compared the safety and efficacy of Mycapssa to monthly injectable somatostatin analogs and has “strongly recommended” that the company start a randomized, double-blind and controlled trial with patients that is long enough to guarantee stable control of disease activity.

The FDA also called for the correction of “certain deficiencies” that were uncovered during an inspection at a facility belonging to one of Chiasma’s suppliers.

 

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