JANUARY 23, 2015 I Santen Pharmaceutical Co., Ltd. (Osaka, JAPAN, Tokyo Stock Exchange Code 4536) (Santen) today announced that Santen S.A.S., its subsidiary in France, received a positive opinion recommending the granting of a marketing authorization for Ikervis®, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Santen submitted a Marketing Authorization Application (MAA) under the centralized procedure for Ikervis® in December 2013. The CHMP based its positive opinion on its review of the comprehensive data package for Ikervis ®. Ikervis® was granted a positive opinion for the “treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes”.
The active substance of Ikervis® is ciclosporin, an immunosuppressant, belonging to the therapeutic class of ophthalmic products. Ciclosporin blocks the release of pro-inflammatory cytokines and exerts an anti- inflammatory effect in ocular surface cells. The benefits with Ikervis are its ability to improve ocular surface damage and reduce inflammation in dry eye disease patients with severe keratitis.
About Santen
As a specialty company dedicated to the ophthalmic and anti-rheumatic fields, Santen carries out the research, development, sales, and marketing of pharmaceuticals. The company has 15 bases in 12 countries globally and delivers products to consumers in more than 70 countries. In Japan, Santen holds the No. 1 share in the prescription ophthalmic pharmaceutical market. 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.
SOURCE: Santen
Post Views: 21
JANUARY 23, 2015 I Santen Pharmaceutical Co., Ltd. (Osaka, JAPAN, Tokyo Stock Exchange Code 4536) (Santen) today announced that Santen S.A.S., its subsidiary in France, received a positive opinion recommending the granting of a marketing authorization for Ikervis®, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Santen submitted a Marketing Authorization Application (MAA) under the centralized procedure for Ikervis® in December 2013. The CHMP based its positive opinion on its review of the comprehensive data package for Ikervis ®. Ikervis® was granted a positive opinion for the “treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes”.
The active substance of Ikervis® is ciclosporin, an immunosuppressant, belonging to the therapeutic class of ophthalmic products. Ciclosporin blocks the release of pro-inflammatory cytokines and exerts an anti- inflammatory effect in ocular surface cells. The benefits with Ikervis are its ability to improve ocular surface damage and reduce inflammation in dry eye disease patients with severe keratitis.
About Santen
As a specialty company dedicated to the ophthalmic and anti-rheumatic fields, Santen carries out the research, development, sales, and marketing of pharmaceuticals. The company has 15 bases in 12 countries globally and delivers products to consumers in more than 70 countries. In Japan, Santen holds the No. 1 share in the prescription ophthalmic pharmaceutical market. 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.
SOURCE: Santen
Post Views: 21
