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US FDA Requests Additional Information for Santen Prior to Approval of NDA for Intravitreal Sirolimus.

M2 PHARMA-December 26, 2017-US FDA Requests Additional Information for Santen Prior to Approval of NDA for Intravitreal Sirolimus

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- The US Food and Drug Administration has issued a complete response letter to Emeryville, California-based ophthalmology company Santen Inc. and Osaka, Japan-based Santen Pharmaceutical Co., Ltd. for the new drug application (NDA) for intravitreal (IVT ) sirolimus (DE-109), the company said.

IVT sirolimus, being evaluated as a potential treatment for adults with noninfectious uveitis of the posterior segment (intermediate, posterior, and panuveitis), is a locally-administered, non-steroidal immunoregulator that has been investigated for the resolution of intraocular inflammation associated with noninfectious uveitis of the posterior segment.

The complete response letter (CRL) indicates that the FDA is unable to approve the application in its present form and requests additional substantiating evidence to demonstrate efficacy of IVT sirolimus in the treatment of noninfectious uveitis of the posterior segment.

The CRL is not expected to have a material impact on FY2017 earnings forecasts.

The NDA for IVT sirolimus was supported by the results from the SAKURA (Sirolimus study Assessing double-masKed Uveitis tReAtment) Program, which included two multi-national, randomized, double-masked, active-controlled studies in adult patients with active non-infectious intermediate, posterior, or panuveitis.

As a specialty company dedicated to the ophthalmic field, Santen carries out research, development, marketing, and sales of pharmaceuticals. The company aims to supply products and services to satisfy unmet medical needs.

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Date:Dec 26, 2017
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