OSAKA, Japan--(BUSINESS WIRE)--Santen Pharmaceutical Co., Ltd. (hereinafter, “Santen”), a specialized ophthalmology company headquartered in Osaka, Japan, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravitreal (IVT) sirolimus (440 µg), development code DE-109, for the treatment of non-infectious uveitis of the posterior segment (NIU-PS). The FDA has set an action date of December 24, 2017 to complete its review of the IVT sirolimus NDA, per the Prescription Drug User Fee Act (PDUFA). IVT sirolimus was granted orphan drug designation by the FDA and the European Commission (EC) in 2011.
IVT sirolimus, an mTOR inhibitor, is an investigational first-in-class targeted, immunoregulator being developed by Santen for the treatment of patients with NIU-PS. NIU-PS is a progressive and chronic inflammatory disease of the eye that can lead to vision impairment and blindness. The NDA for IVT sirolimus is supported by data from the SAKURA Program, the largest Phase III global clinical program to date evaluating patients with NIU-PS.
“The FDA acceptance of the NDA for IVT sirolimus is an important milestone, and brings us closer to potentially offering a locally-administered treatment option for patients with NIU-PS,” said Naveed Shams, M.D. Ph.D, Chief Scientific Officer and Head of Global R&D at Santen.
About IVT Sirolimus
IVT
sirolimus (440 µg), an mTOR inhibitor, is a first-in-class targeted
immunoregulator being developed for the treatment of NIU-PS – a
progressive and chronic inflammatory disease of the eye. IVT sirolimus
inhibits the protein kinase, mTOR, which plays a key role in
inflammation. The result is immunoregulation by: interrupting the
inflammatory cascade through the inhibition of T-cell activation,
differentiation and proliferation; and, promoting immune tolerance,
increasing regulatory T lymphocytes (Tregs).
About Uveitis
Uveitis is a
leading cause of preventable blindness in working-age adults and is
estimated to account for 10 to 15 percent of cases of total blindness in
the developed world.1 It is characterized by intraocular
inflammation that is often chronic, can flare up at any time and can
lead to visual impairment and vision loss. NIU-PS includes intermediate,
posterior and panuveitis.
About Santen
As a specialty
company dedicated to the ophthalmic field, Santen carries out research,
development, marketing, and sales of pharmaceuticals and devices. Santen
is the market leader in Japan for prescription ophthalmic
pharmaceuticals and sells products in over 50 countries. As a leading
company in the field of ophthalmology, Santen aims to contribute to
society by supplying valuable products and services to satisfy unmet
medical needs. For more details, please see Santen’s website (www.santen.com).
Santen Forward-looking Statements
Information
provided in this press release contains so-called “Forward-looking
Statements.” The realizations of these forecasts are subject to risk and
uncertainty from various sources. Therefore, please note that the actual
results may differ significantly from the forecasts. Business
performance and financial condition are subject to the effects of change
in regulations made by the governments of Japan and other nations
concerning medical insurance, drug pricing and other systems, and to
fluctuations in market variables such as interest rates and foreign
exchange rates.
1 Durrani OM, Tehrani NN, Marr JE, Moradi P, Stavrou P, Murray PI. Degree, duration, and causes of visual loss in uveitis. Br J of Ophthalmol. 2004;88(9):1159-1162.
Santen Pharmaceutical Co., Ltd.
Christopher Hohman, General
Manager, Corporate Communications Group
Tel: +81-6-4802-9360
E-mail:
ir@santen.co.jp