KUALA LUMPUR, March 25 (Bernama) -- The Marketing Authorization
Application (MAA) for Ikervis has been approved by the European
Commission (EC) to treat severe keratitis disease of the eye, said
Santen Pharmaceutical Co., Ltd, in a statement issued today in Osaka,
Japan.
The MAA approval is supported by a phase III clinical program investigating the efficacy and safety of ciclosporin in European dry eye disease patients with severe keratitis, which shows no improvement despite treatment with tear substitutes.
Based on quality, safety and efficacy data submitted, Ikervis had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency in January, 2015.
The CHMP considered that there was a favorable benefit-to-risk balance for Ikervis and therefore recommended the granting of the marketing authorization.
It is the first drug for the treatment of severe keratitis in adult patients with dry eye disease in Europe.
"We are delighted with today's MAA approval that offers dry eye disease patients with severe keratitis the first prescription treatment in Europe.
"Our commitment is to continue to deliver new treatments for people suffering from dry eye. Ikervis is a tangible result of Santen's patient-centered approach to innovation," commented Masamichi Sato, Head of Santen Europe and President of Santen Holdings EU B.V. in the same statement.
--BERNAMA
The MAA approval is supported by a phase III clinical program investigating the efficacy and safety of ciclosporin in European dry eye disease patients with severe keratitis, which shows no improvement despite treatment with tear substitutes.
Based on quality, safety and efficacy data submitted, Ikervis had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency in January, 2015.
The CHMP considered that there was a favorable benefit-to-risk balance for Ikervis and therefore recommended the granting of the marketing authorization.
It is the first drug for the treatment of severe keratitis in adult patients with dry eye disease in Europe.
"We are delighted with today's MAA approval that offers dry eye disease patients with severe keratitis the first prescription treatment in Europe.
"Our commitment is to continue to deliver new treatments for people suffering from dry eye. Ikervis is a tangible result of Santen's patient-centered approach to innovation," commented Masamichi Sato, Head of Santen Europe and President of Santen Holdings EU B.V. in the same statement.
--BERNAMA
http://www.bernama.com/bernama/v8/newsindex.php?id=1120739
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