Marketing Authorization Application For Lipsovir(R) Submitted To European Regulatory Authorities

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Oct 2008 - 6:00 PDT

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Medivir (STO:MVIRB) has now submitted an application for marketing authorization to the European regulatory authorities for Lipsovir®, a topical product for prevention and treatment of cold sores.

Lipsovir® is a patented combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) in a proprietary cream base developed by Medivir.

The clinical phase III program demonstrated that the development of cold sores can be prevented with early treatment initiation, an effect that currently available products for this indication lack. Lipsovir® thereby provides individuals prone to recurrent cold sores with a clinically important benefit compared to currently available products.

"We have achieved a substantial and important milestone for Lipsovir® in filing registration applications in both USA and Europe", says Börje Darpö, Head of Medivir's clinical development department.

For more information on Medivir, please see the company website http://www.medivir.se

Source
Rein Piir
http://www.medivir.se