my.bionity.com
With an accout for my.bionity.com you can always see everything at a glance – and you can configure your own website and individual newsletter.
02-08-2012: Clinuvel Pharmaceuticals Limited announced that it has submitted a marketing authorisation application (MAA) for its first-in-class drug SCENESSE® (afamelanotide 16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a prophylactic treatment in adult patients with erythropoietic protoporphyria (EPP), a rare disease which causes absolute intolerance of patients’ skin to light.
SCENESSE®, which received an orphan drug designation for EPP in 2008, will be reviewed under the EMA’s Centralised Procedure. An approval under this scheme will allow Clinuvel to market SCENESSE® in all 27 European Union member states as well as Norway, Iceland and Liechtenstein.
“We are confident that we have provided sufficient data to demonstrate that SCENESSE® is a safe and clinically meaningful treatment for EPP,” Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said. “We firmly believe that our application will withstand the rigor of the regulatory review.”
“This filing is an important milestone in the evolution of Clinuvel, and is another landmark among the innovative therapies developed by the biotech sector, as afamelanotide is the first ever melanocortin filed for marketing approval,” Clinuvel’s CEO, Dr Philippe Wolgen said. “In the coming months we will continue our constructive dialogue with the regulatory authorities in order to bring this much-needed therapy to the EPP community across Europe.”
Contact / Request information
Request further information free of charge:
Watchlist
This is where you can add this news to your personal favourites
Clinuvel files European marketing authorisation application for SCENESSE (afamelanotide)
Clinuvel Pharmaceuticals Limited announced that it has submitted a marketing authorisation application (MAA) for its first-in-class drug SCENESSE® (afamelanotide 16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a prophylactic treatment in adult pa ... more
Clinuvel Pharmaceuticals Limited announced that final analyses of its confirmatory Phase III European study (CUV029) in erythropoietic protoporphyria (EPP) has shown a clinically relevant positive prophylactic treatment effect for patients who had been administered SCENESSE® (afamelanotide ... more
Clinuvel's afamelanotide to commence US patient trials for absolute light intolerance
An Australian drug to protect patients who are intolerant of light and sunlight will begin trials in the US next month. The US Food and Drug Administration (FDA) has given clearance to Melbourne’s Clinuvel Pharmaceuticals to commence a Phase II study (CUV030) of its drug, afamelanotide, in ... more
Clinuvel Pharmaceuticals Limited
Clinuvel Pharmaceuticals Limited is an Australian biopharmaceutical company with offices in San Francisco and Zürich developing its photoprotective drug afamelanotide as a preventative treatment for a range of UV-related skin disorders as well as cancer related treatments. Clinuvel focuse ... more
Genzyme gets Regulatory Approvals of Expanded Waterford Manufacturing Plant
Genzyme, a Sanofi company, announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second suite for filling and finishing product at its Waterford, Ireland manufacturing plant. With this approval, Genzyme has nearly doubled its ability ... more
Clinuvel files European marketing authorisation application for SCENESSE (afamelanotide)
Clinuvel Pharmaceuticals Limited announced that it has submitted a marketing authorisation application (MAA) for its first-in-class drug SCENESSE® (afamelanotide 16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a prophylactic treatment in adult pa ... more
Novartis drug Signifor recommended by CHMP for EU approval to treat patients with Cushing's disease
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Signifor® (SOM230, pasireotide) for the treatment of Cushing's disease. There are currently no approved medicines in the European Union (EU) targeting Cushing's di ... more
European Medicines Agency (EMA)
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. more
About CHEMIE.DE
CHEMIE.DE Information Service GmbH runs specialist scientific internet portals. The secret to our success? We are familiar with what we publish.
Advertising at CHEMIE.DE
Our advertising formats support you in getting your message across to a clearly defined target audience.
© 1997-2012 CHEMIE.DE Information Service GmbH, All rights reserved
